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Future of Swedish and Danish Life Science Event at Medicon Village, Lund, Sweden
Global Regulatory Services at Medicon Valley Alliance in Copenhagen
EU Medical Device and IVD Regulations have been published - there's no turning back!
The UK’s Psychoactive Substances Bill could mean jail for those buying herbal remedies
Precision Medicine Catapult comes to Cambridge?
TOPRA Awards 2014 – an opportunity to say “thank you” to regulatory affairs professionals
Pharmaceuticals, diabetes and beer?
From Lab to Market: CUSPE Lecture, Friday 14 March 2014 (Cambridge)
“Threats to everyone everywhere, is a threat to the individual anywhere”
A tribute to Professor Man Fong Mei: A pioneer in Chinese medicine and East-West integration
The Daily Telegraph states “We’ve cracked it”
Research – Greer Deal's firsthand experience as a ‘patient’
Are CROs driving job creation in life sciences?
What’s new at the Cambridge Biomedical Campus?
End of unlicensed herbal remedies on UK market - deadline 30 April 2014
Digital Connectivity in Cities: the role of policy
The BLOODHOUND Super Sonic Car (SSC): is this UK open innovation at its best?
Top 12 botanicals for health benefits
Ethics & GCP Forum: 30 years of traceability records and silk is best!
European Medical Device Regulations - So What's New?
BSI Consultants' Day - Medical Device Directives Revision and how it will affect your customers
Cambridge Network / Cheffins Fine Art sale preview event
M11 Med-Tech Forum: New Medical Device Regulations - what are the possible changes?
Convergent Medical Technologies - Opportunities and Challenges
London Stansted Corridor Consortium - Inaugural Event and GRS was there!
Sharing the China Experience - GRS/APTN event
London Regenerative Medicine Event, 19 November 2012
London House debate on: "The Environment Imperative", 1 August 2012
Zurich Life Science Day, House of Switzerland UK, 30 July 2012
EU: Antibiotic Awareness Day, 18th November 2012
Next Vitafoods Europe Event to be held in Geneva, 14-16 May 2013
One Nucleus BioWednesday London: Partnering with AstraZeneca - making the process more transparent
"The Truth about Sports Products" BBC Panorama Programme
Science, Sport and the London 2012 Olympics
Why antibiotics are losing the war against bacteria
First meeting with UK's Parliamentary & Scientific Committee
Chinese Herbal Medicines: Greer Deal, Director of GRS, co-authors two key papers
Cambridge Phenomenon Book Launch, May 2012
Final Conference of Good Practice in Traditional Chinese Medicine (GP-TCM)
Will Asian Traditional Medicines ‘grow’ in Europe?
Parkinson's Disease: past, present and future
US: Cannabis and cancer treatment
EU: Health Food Shop owners may be gagged, says M.E.P. Marian Harkin
EU Herbals and Foods - recent reports
GSK invests in UK manufacturing - is this the start of a brighter future?
You can also contribute to the European Committee for Advanced Therapies (CAT)
Would you like to make a difference? Please read on ...
NHS workshop at Bench-to-Boardroom event a great success
Research & Development (R&D) Incentives – Australia and UK
UK Department of Health (DoH) and implied health claims
Instead of “STEM” perhaps read “STEAM” says Peter Barron, Google’s Head of External Relations
China Evening: Cambridge 100 Club Dinner
Umbilical cord blood hits the news again
China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine
"Homeopathic treatment is both effective and cost-effective" says Swiss Government
AstraZeneca to axe 7,300 jobs worldwide - what's the impact on the UK?
UK: "Regulator under fire on faulty implants" - MHRA's response to The Financial Times
The terms "herbal", "natural" don't guarantee a remedy is safe
Pharma giants joining forces to combat tropical diseases
Grape seed extract could be an anti-cancer treatment of the future
EMA's concept paper on pharmacogenomics in evaluation of authorised medicines
Cord blood banking: Charitable, clinical and commercial
UK: Cannabis company enjoys major growth
Mobile Technology and Smart Barcodes
UK: Cardiovascular disease - another exciting scientific advance
UK: First MHRA approved Mobile Phone App Released
US: new ingredient quality standards for inclusion in the Food Chemicals Codex (FCC)
UK: new home page for MHRA website launched 7th January 2012
Ireland: Guide to Clinical Trial Applications
UK herbal medicines quality campaign launches at Westminster
Nutraceuticals - EU gives Ђ3m to genomic modelling project
Global neutraceutical ingredient market to grow 7.2% pa reaching Ђ18.5 billion by 2015
US and EU: the US FDA and EMA will share work in relation to GMP inspections
UK: consultation on food additives - make sure you have your say
EU: Consumer friendly juice labelling rules approved
Are phone apps the way forward to ensure compliance re food health claims?
The European Commission has issued a concept paper on the requirement for safety features in line with the falsified medicines l
US: New Dietary Ingredient Notifications Guidance - negative response from two key organisations
Antibiotic Action - a UK led global initiative
UK: MHRA sets up a new forum for Good Clinical Practice (GCP)
East Meets West in US Hospitals
EU hails ground-breaking nano definition
Does the European ban on stem-cell patents have a silver lining?
Medical Devices - hacking of software
UK: MHRA publish formal consultation on draft consolidation and review of UK medicines legislation
EU: Inneov calls for complete EU health claims revamp
US: industry decides safety of about one third of food additives
Chinese pharma eyes opportunity in U.S. and U.K.
UK: Decentralised Procedure (DCP) update and 'slot' availability
Europe: Classification, packaging and labelling of nanomaterials
UK: Weaving an untangled web – extension of the ASA’s online remit
Europe’s Revised Information Proposals: An Olive Branch to Patients and Industry?
Russia: Innovative cancer drugs on new essential list
USA: FDA Commissioner outlines plan to speed new drug development
USA: Orphan drugs win favored status in FDA reviews
French BPA ban will distort EU food packaging market
Europe: EMA Invites Feedback on Biosimilar and Vaccine Concept Papers
Irish Medicines Board (IMB): update to fee guide for veterinary products 2011
US: Cloned human embryo makes working stem cells
EU: New Medical Cluster established in South Germany
Canada pilots model clinical trial agreement
EU adopts Food Information Regulation
EU: Danish fat tax divides UK opinion
EU: Italian academics say that ignoring 'tradition-of-use' data bashes botanicals
UK: MHRA updated guidance for the advertising of medicines
US: New FDA Guidance on User Fee Waivers, Reductions, and Refunds
US FDA Publishes Guidance on Marketed Unapproved Drugs
EU: Cosmetic Ingredients Under EU Scrutiny
US: Industry steams ahead with FOP labelling scheme
US: Foods and Veterinary Program (FVM) Strategic Plan for 2012-2016
UK: Reminder to cancel medicines licences by the end of December 2011
US structure/function claims about foods and supplements are under scrutiny
US FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review
Europe: Updates to Good Distribution Practice section
UK: Taking stock of regenerative medicine
UK: Labelling and packaging of medicines: Quick Response (QR) codes
France abolishes maximum levels for some vitamins
Australia: Regulatory framework for biologicals
US FDA guidance on biosimilars may be imminent
Europe: Groundbreaking embryonic stem cell study gets green light
Europe: Medical Device Usability Requirements
Europe: Medical Devices - The Notified Body Consultation Procedure, Part 2
Europe: Medical Devices - The Notified Body Consultation Procedure, Part 1
Europe: Academia and industry push for revisions to Clinical Trials Directive
India: In October 2011, barcodes will become mandatory on the packaging of exported drugs
Canada: Health Canada publishes probiotics monograph
US: President Obama Signs America Invents Act, overhauling the Patent System
UK FSA - SMEs still need guidance for alternative colourings to the "Southampton Six"
EFSA warns that EU could be vulnerable to food safety threats
UK: Compliance reports for Good Pharmacovigilance Practice
Bobby Deal of Global Regulatory Services (GRS) flies high for his birthday!
FDA: Moving Regulatory Science into the 21st Century
Antioxidants & botanicals expected to help drive US Cosmeceutical growth to $8.5 Billion by 2015
Finding new ways to battle HIV - stem cell therapy may help
Why are some people are more likely to gain weight around their midsection? Stem cells may help.
Stem Cells and Autism
IFT to lead FDA product tracing pilot studies
Strong America Ltd Issues Alert on Undeclared Sulfites in Huipu Chinese Wolfberry
EFSA Health Claims, Batch 4 - winners and losers
Europe: EC expects "smooth adoption" of article 13 health claims list in Q1 of 2012
Chromadex seals African botanical standards deal
Europe: First Paediatric Use Marketing Authorisation (PUMA) is granted
British Herbal Medicine Association (BHMA) says THMPD is a good thing for the industry
Australia: Complementary Medicines - compositional guideline template
US Center for Food Safety and Applied Nutrition - New requirement to be enforced 6 September 2011
Useful website? Explore Stem Cells - www.explorestemcells.co.uk
USA: Draft Guidance re In Vitro Companion Diagnostic Devices
Australia: Overview of the regulatory framework for in-vitro diagnostic medical devices
USA: The term "cosmeceutical" has no meaning under the law
USA: Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use
Article: The Global Herbs & Botanicals Market - trends etc
UK: The MHRA has launched a feed on Twitter about herbal remedies.
GRS features in Business Weekly
Europe: New Directive on Falsified Medicines
So how far would you go to test your product - space?
Milk From ‘Spider Goats' Could Produce Tendon Replacement Material
Australia: Evaluation of a new medicine - The TGA's lifecycle approach to regulation
USA: FDA releases New Dietary Ingredient (NDI) draft guidance (July 2011)
EFSA publishes article 13, batch 5 – winners and losers
30 June 2011: EFSA publishes fifth series of evaluations of ‘general function’ health claims
CellFATE, the Federation for Advanced Therapies in Europe
US FDA Proposes New Policy for Some Diagnostic and Radiology Devices
Europe: European Medicines Agency publishes format for submission of information on medicines
Australia: pharmacovigilance guideline for sponsors amended
Australia: Revised TGA fees & charges
Korea: Implant Mimics Cancellous and Cortical Bone
US: Durbin to Introduce Legislation Designed to Protect Consumers of Dietary Supplements
IADSA releases a free global GMP guide for supplements makers
FDA data supports bitter orange safety
MHRA Update: herbal safety warnings
FDA update: Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h)
FDA Update: Classification of Products as Drugs and Devices and Additional Product Classification Issues
Australia: release of therapeutic goods for supply
UK News: Fatal cocktail of common drugs putting elderly at risk
EU finally funds its way to a unitary patent
Advanced Cell Technology to begin stem cell trials for eye diseases
Why did FDA change their Guideline on Process Validation?
ABCEurope BioEntrepreneur Bootcamp - GRS presented to budding entrepreneurs
New stem cell centre for King’s College London
EU Commission to ditch dietetic foods category
US FDA launches special report on Pathway to Global Product Safety and Quality
Response to EU Commission's Concept Paper on revision of the Clinical Trials Directive 2001/20/
EFSA Scientific Opinion on the safety of a ‘fermented black bean extract (Touchi extract)’ as a Novel Food ingredient
EFSA Scientific Opinion on the safety of ‘yeast beta-glucans’ as a Novel Food ingredient
FDA's CDER Addresses 'Challenges of Globalization' With a New Office
Creating Hope For Orphan Diseases
Out-Of-Specification (OOS) Result Handling Continues as Dominant Theme in FDA Warning Letters
EFSA rejects Danone and Yakult probiotic appeals
USA approves new cancer drugs faster than EMA: study
Europe should be generics global powerhouse
EU-wide nanotech register vital to ensure safety, says ETUI
Denmark: There is no Marmite ban
European Medical Device Usability Requirements
US Functional food market up 31% since 2006, says new report
Nestlй and King's College commit to ‘protein-protein’ nutrigenomics project
The US FDA announces significant changes to Over-The-Counter sunscreen products
Nanotechnology - FDA takes 'first step' toward greater regulatory certainty
Japan lead under threat in global Ђ16.75bn functional foods market
New 'alternative medicine' web portal is available for healthcare providers
EU “General function” health claims under Article 13 - ban on rejected claims likely in 2012
Food Safety Week (UK), 6 to 12 June 2011
E-submissions for new medical devices
Non European 'dot com' websites can be affected by the EU Herbal Directive
GRS & Pilgrim Partner announcement
Herbal News in Brief: GP-TCM in the post-genomic era
Botanicals/Natural Products Meeting Report, Genesis 2010
A fresh take on Traditional Medicine - University of Sydney
UK regulation of herbal practitioners
People warned over adulterated herbal weight loss pill
8 March 2011: Bench to Boardroom Event, GRS to host roundtable workshop
GRS to co-host Botanicals and Natural products stream as a pilot at Genesis 2009
UKTI: Passport to Export Programme - GRS to present
GRS to present at London Conference "Potent Substances: on the Boundaries of Food and Medicine", 13-15 September 2010
GRS presents at London First Event "The Business of Healthcare in London", 25 May 2010
Announcement: GRS to host Botanicals and Natural products Stream at Genesis 2010
Overview and update on EU directive 2004/24/EC: Traditional herbal medicines (peer reviewed article)
European and Non-European Paediatric Clinical Trials (peer reviewed article)
Stem Cell Therapy Regulations: The US vs the EU (peer reviewed article)
The Herbal Directive – is it the proverbial "sledgehammer to crack a nut"?
Macmillan Cancer Support, Cambridge - programme of events
Macmillan Cancer Support, Cambridge - programme of events
Press Release: GRS and Macmillan Cancer Support Charity
Press Release: Global Regulatory Services (GRS) and GlaxoSmithKline
Natural Health Products: Challenges and Opportunities in the UK (Article)
The European Herbal Directive: Friend or Foe? (Article)
Press Release: Global Regulatory Services (GRS) and China
Press Release: New Botanicals Stream announced ...
Riding the Credit Crunch Rollercoaster (article)
Nutraceuticals – Foods or Medicines? (Article)
Can Stem Cell therapy become an integral part of our healthcare? (article)
The Future of Herbal Medicines within Modern Society
China: can traditional and modern medicinal products live in harmony? (Article)
Children, Drugs and the EU Paediatric Initiative (article)
"Britain is not on its knees" states Digby, Lord Jones of Birmingham (meeting report)
Global Regulatory Services (GRS) - updated website

US: New FDA Guidance on User Fee Waivers, Reductions, and Refunds

02/10/2011

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds, or reductions in prescription drug user fees.

 

The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.

 

Under the Prescription Drug User Fee Act (PDUFA), FDA is authorized to assess application fees for certain human drug and biological product applications or supplements. In addition, FDA can assess annual product fees for certain approved drug and biological products, and annual establishment fees for the facilities in which those products are made. 

 

Author: Greer Deal, Director of Global Regulatory Services (GRS)

Past Posts...

Future of Swedish and Danish Life Science Event at Medicon Village, Lund, Sweden
30 March 2018
Global Regulatory Services at Medicon Valley Alliance in Copenhagen
21 March 2018
EU Medical Device and IVD Regulations have been published - there's no turning back!
5 May 2017
The UK’s Psychoactive Substances Bill could mean jail for those buying herbal remedies
5 July 2015
Precision Medicine Catapult comes to Cambridge?
1 February 2015
TOPRA Awards 2014 – an opportunity to say “thank you” to regulatory affairs professionals
1 June 2014
Pharmaceuticals, diabetes and beer?
30 March 2014
From Lab to Market: CUSPE Lecture, Friday 14 March 2014 (Cambridge)
18 March 2014
“Threats to everyone everywhere, is a threat to the individual anywhere”
13 March 2014
A tribute to Professor Man Fong Mei: A pioneer in Chinese medicine and East-West integration
8 March 2014
The Daily Telegraph states “We’ve cracked it”
5 February 2014
Research – Greer Deal's firsthand experience as a ‘patient’
5 December 2013
Are CROs driving job creation in life sciences?
4 December 2013
What’s new at the Cambridge Biomedical Campus?
4 December 2013
End of unlicensed herbal remedies on UK market - deadline 30 April 2014
21 November 2013
Digital Connectivity in Cities: the role of policy
21 November 2013
The BLOODHOUND Super Sonic Car (SSC): is this UK open innovation at its best?
10 November 2013
Top 12 botanicals for health benefits
10 November 2013
Ethics & GCP Forum: 30 years of traceability records and silk is best!
5 November 2013
European Medical Device Regulations - So What's New?
2 November 2013
BSI Consultants' Day - Medical Device Directives Revision and how it will affect your customers
2 November 2013
Cambridge Network / Cheffins Fine Art sale preview event
2 November 2013
M11 Med-Tech Forum: New Medical Device Regulations - what are the possible changes?
2 November 2013
Convergent Medical Technologies - Opportunities and Challenges
1 November 2013
London Stansted Corridor Consortium - Inaugural Event and GRS was there!
1 November 2013
Sharing the China Experience - GRS/APTN event
1 November 2013
London Regenerative Medicine Event, 19 November 2012
1 November 2013
London House debate on: "The Environment Imperative", 1 August 2012
2 September 2013
Zurich Life Science Day, House of Switzerland UK, 30 July 2012
2 September 2013
EU: Antibiotic Awareness Day, 18th November 2012
18 November 2012
Next Vitafoods Europe Event to be held in Geneva, 14-16 May 2013
26 July 2012
One Nucleus BioWednesday London: Partnering with AstraZeneca - making the process more transparent
22 July 2012
"The Truth about Sports Products" BBC Panorama Programme
21 July 2012
Science, Sport and the London 2012 Olympics
19 July 2012
Why antibiotics are losing the war against bacteria
15 July 2012
First meeting with UK's Parliamentary & Scientific Committee
28 June 2012
Chinese Herbal Medicines: Greer Deal, Director of GRS, co-authors two key papers
8 June 2012
Cambridge Phenomenon Book Launch, May 2012
7 June 2012
Final Conference of Good Practice in Traditional Chinese Medicine (GP-TCM)
31 May 2012
Will Asian Traditional Medicines ‘grow’ in Europe?
16 May 2012
Parkinson's Disease: past, present and future
13 May 2012
US: Cannabis and cancer treatment
2 May 2012
EU: Health Food Shop owners may be gagged, says M.E.P. Marian Harkin
24 March 2012
EU Herbals and Foods - recent reports
24 March 2012
GSK invests in UK manufacturing - is this the start of a brighter future?
24 March 2012
You can also contribute to the European Committee for Advanced Therapies (CAT)
22 March 2012
Would you like to make a difference? Please read on ...
22 March 2012
NHS workshop at Bench-to-Boardroom event a great success
13 March 2012
Research & Development (R&D) Incentives – Australia and UK
2 March 2012
UK Department of Health (DoH) and implied health claims
1 March 2012
Instead of “STEM” perhaps read “STEAM” says Peter Barron, Google’s Head of External Relations
29 February 2012
China Evening: Cambridge 100 Club Dinner
20 February 2012
Umbilical cord blood hits the news again
19 February 2012
China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine
19 February 2012
"Homeopathic treatment is both effective and cost-effective" says Swiss Government
19 February 2012
AstraZeneca to axe 7,300 jobs worldwide - what's the impact on the UK?
7 February 2012
UK: "Regulator under fire on faulty implants" - MHRA's response to The Financial Times
2 February 2012
The terms "herbal", "natural" don't guarantee a remedy is safe
2 February 2012
Pharma giants joining forces to combat tropical diseases
2 February 2012
Grape seed extract could be an anti-cancer treatment of the future
31 January 2012
EMA's concept paper on pharmacogenomics in evaluation of authorised medicines
27 January 2012
Cord blood banking: Charitable, clinical and commercial
26 January 2012
UK: Cannabis company enjoys major growth
24 January 2012
Mobile Technology and Smart Barcodes
18 January 2012
UK: Cardiovascular disease - another exciting scientific advance
18 January 2012
UK: First MHRA approved Mobile Phone App Released
12 January 2012
US: new ingredient quality standards for inclusion in the Food Chemicals Codex (FCC)
9 January 2012
UK: new home page for MHRA website launched 7th January 2012
9 January 2012
Ireland: Guide to Clinical Trial Applications
9 January 2012
UK herbal medicines quality campaign launches at Westminster
9 January 2012
Nutraceuticals - EU gives Ђ3m to genomic modelling project
9 January 2012
Global neutraceutical ingredient market to grow 7.2% pa reaching Ђ18.5 billion by 2015
9 January 2012
US and EU: the US FDA and EMA will share work in relation to GMP inspections
16 December 2011
UK: consultation on food additives - make sure you have your say
16 December 2011
EU: Consumer friendly juice labelling rules approved
16 December 2011
Are phone apps the way forward to ensure compliance re food health claims?
11 December 2011
The European Commission has issued a concept paper on the requirement for safety features in line with the falsified medicines l
7 December 2011
US: New Dietary Ingredient Notifications Guidance - negative response from two key organisations
7 December 2011
Antibiotic Action - a UK led global initiative
11 November 2011
UK: MHRA sets up a new forum for Good Clinical Practice (GCP)
1 November 2011
East Meets West in US Hospitals
30 October 2011
EU hails ground-breaking nano definition
30 October 2011
Does the European ban on stem-cell patents have a silver lining?
30 October 2011
Medical Devices - hacking of software
30 October 2011
UK: MHRA publish formal consultation on draft consolidation and review of UK medicines legislation
30 October 2011
EU: Inneov calls for complete EU health claims revamp
30 October 2011
US: industry decides safety of about one third of food additives
30 October 2011
Chinese pharma eyes opportunity in U.S. and U.K.
30 October 2011
UK: Decentralised Procedure (DCP) update and 'slot' availability
14 October 2011
Europe: Classification, packaging and labelling of nanomaterials
13 October 2011
UK: Weaving an untangled web – extension of the ASA’s online remit
13 October 2011
Europe’s Revised Information Proposals: An Olive Branch to Patients and Industry?
13 October 2011
Russia: Innovative cancer drugs on new essential list
13 October 2011
USA: FDA Commissioner outlines plan to speed new drug development
13 October 2011
USA: Orphan drugs win favored status in FDA reviews
13 October 2011
French BPA ban will distort EU food packaging market
13 October 2011
Europe: EMA Invites Feedback on Biosimilar and Vaccine Concept Papers
11 October 2011
Irish Medicines Board (IMB): update to fee guide for veterinary products 2011
7 October 2011
US: Cloned human embryo makes working stem cells
6 October 2011
EU: New Medical Cluster established in South Germany
6 October 2011
Canada pilots model clinical trial agreement
4 October 2011
EU adopts Food Information Regulation
4 October 2011
EU: Danish fat tax divides UK opinion
4 October 2011
EU: Italian academics say that ignoring 'tradition-of-use' data bashes botanicals
3 October 2011
UK: MHRA updated guidance for the advertising of medicines
3 October 2011
US: New FDA Guidance on User Fee Waivers, Reductions, and Refunds
2 October 2011
US FDA Publishes Guidance on Marketed Unapproved Drugs
2 October 2011
EU: Cosmetic Ingredients Under EU Scrutiny
2 October 2011
US: Industry steams ahead with FOP labelling scheme
1 October 2011
US: Foods and Veterinary Program (FVM) Strategic Plan for 2012-2016
1 October 2011
UK: Reminder to cancel medicines licences by the end of December 2011
29 September 2011
US structure/function claims about foods and supplements are under scrutiny
29 September 2011
US FDA Issues Draft Guidance on Device Changes That Warrant New Premarket Review
29 September 2011
Europe: Updates to Good Distribution Practice section
29 September 2011
UK: Taking stock of regenerative medicine
29 September 2011
UK: Labelling and packaging of medicines: Quick Response (QR) codes
29 September 2011
France abolishes maximum levels for some vitamins
29 September 2011
Australia: Regulatory framework for biologicals
29 September 2011
US FDA guidance on biosimilars may be imminent
27 September 2011
Europe: Groundbreaking embryonic stem cell study gets green light
27 September 2011
Europe: Medical Device Usability Requirements
27 September 2011
Europe: Medical Devices - The Notified Body Consultation Procedure, Part 2
27 September 2011
Europe: Medical Devices - The Notified Body Consultation Procedure, Part 1
27 September 2011
Europe: Academia and industry push for revisions to Clinical Trials Directive
27 September 2011
India: In October 2011, barcodes will become mandatory on the packaging of exported drugs
27 September 2011
Canada: Health Canada publishes probiotics monograph
27 September 2011
US: President Obama Signs America Invents Act, overhauling the Patent System
23 September 2011
UK FSA - SMEs still need guidance for alternative colourings to the "Southampton Six"
23 September 2011
EFSA warns that EU could be vulnerable to food safety threats
23 September 2011
UK: Compliance reports for Good Pharmacovigilance Practice
21 September 2011
Bobby Deal of Global Regulatory Services (GRS) flies high for his birthday!
18 September 2011
FDA: Moving Regulatory Science into the 21st Century
18 September 2011
Antioxidants & botanicals expected to help drive US Cosmeceutical growth to $8.5 Billion by 2015
18 September 2011
Finding new ways to battle HIV - stem cell therapy may help
18 September 2011
Why are some people are more likely to gain weight around their midsection? Stem cells may help.
18 September 2011
Stem Cells and Autism
18 September 2011
IFT to lead FDA product tracing pilot studies
18 September 2011
Strong America Ltd Issues Alert on Undeclared Sulfites in Huipu Chinese Wolfberry
18 September 2011
EFSA Health Claims, Batch 4 - winners and losers
18 September 2011
Europe: EC expects "smooth adoption" of article 13 health claims list in Q1 of 2012
18 September 2011
Chromadex seals African botanical standards deal
12 September 2011
Europe: First Paediatric Use Marketing Authorisation (PUMA) is granted
11 September 2011
British Herbal Medicine Association (BHMA) says THMPD is a good thing for the industry
2 September 2011
Australia: Complementary Medicines - compositional guideline template
2 September 2011
US Center for Food Safety and Applied Nutrition - New requirement to be enforced 6 September 2011
2 September 2011
Useful website? Explore Stem Cells - www.explorestemcells.co.uk
17 July 2011
USA: Draft Guidance re In Vitro Companion Diagnostic Devices
17 July 2011
Australia: Overview of the regulatory framework for in-vitro diagnostic medical devices
17 July 2011
USA: The term "cosmeceutical" has no meaning under the law
17 July 2011
USA: Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use
17 July 2011
Article: The Global Herbs & Botanicals Market - trends etc
17 July 2011
UK: The MHRA has launched a feed on Twitter about herbal remedies.
17 July 2011
GRS features in Business Weekly
14 July 2011
Europe: New Directive on Falsified Medicines
12 July 2011
So how far would you go to test your product - space?
12 July 2011
Milk From ‘Spider Goats' Could Produce Tendon Replacement Material
12 July 2011
Australia: Evaluation of a new medicine - The TGA's lifecycle approach to regulation
11 July 2011
USA: FDA releases New Dietary Ingredient (NDI) draft guidance (July 2011)
11 July 2011
EFSA publishes article 13, batch 5 – winners and losers
11 July 2011
30 June 2011: EFSA publishes fifth series of evaluations of ‘general function’ health claims
11 July 2011
CellFATE, the Federation for Advanced Therapies in Europe
11 July 2011
US FDA Proposes New Policy for Some Diagnostic and Radiology Devices
8 July 2011
Europe: European Medicines Agency publishes format for submission of information on medicines
8 July 2011
Australia: pharmacovigilance guideline for sponsors amended
29 June 2011
Australia: Revised TGA fees & charges
29 June 2011
Korea: Implant Mimics Cancellous and Cortical Bone
29 June 2011
US: Durbin to Introduce Legislation Designed to Protect Consumers of Dietary Supplements
29 June 2011
IADSA releases a free global GMP guide for supplements makers
27 June 2011
FDA data supports bitter orange safety
27 June 2011
MHRA Update: herbal safety warnings
27 June 2011
FDA update: Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h)
27 June 2011
FDA Update: Classification of Products as Drugs and Devices and Additional Product Classification Issues
27 June 2011
Australia: release of therapeutic goods for supply
26 June 2011
UK News: Fatal cocktail of common drugs putting elderly at risk
26 June 2011
EU finally funds its way to a unitary patent
26 June 2011
Advanced Cell Technology to begin stem cell trials for eye diseases
26 June 2011
Why did FDA change their Guideline on Process Validation?
23 June 2011
ABCEurope BioEntrepreneur Bootcamp - GRS presented to budding entrepreneurs
22 June 2011
New stem cell centre for King’s College London
22 June 2011
EU Commission to ditch dietetic foods category
21 June 2011
US FDA launches special report on Pathway to Global Product Safety and Quality
21 June 2011
Response to EU Commission's Concept Paper on revision of the Clinical Trials Directive 2001/20/
21 June 2011
EFSA Scientific Opinion on the safety of a ‘fermented black bean extract (Touchi extract)’ as a Novel Food ingredient
20 June 2011
EFSA Scientific Opinion on the safety of ‘yeast beta-glucans’ as a Novel Food ingredient
20 June 2011
FDA's CDER Addresses 'Challenges of Globalization' With a New Office
20 June 2011
Creating Hope For Orphan Diseases
20 June 2011
Out-Of-Specification (OOS) Result Handling Continues as Dominant Theme in FDA Warning Letters
20 June 2011
EFSA rejects Danone and Yakult probiotic appeals
20 June 2011
USA approves new cancer drugs faster than EMA: study
20 June 2011
Europe should be generics global powerhouse
20 June 2011
EU-wide nanotech register vital to ensure safety, says ETUI
19 June 2011
Denmark: There is no Marmite ban
19 June 2011
European Medical Device Usability Requirements
17 June 2011
US Functional food market up 31% since 2006, says new report
17 June 2011
Nestlй and King's College commit to ‘protein-protein’ nutrigenomics project
17 June 2011
The US FDA announces significant changes to Over-The-Counter sunscreen products
14 June 2011
Nanotechnology - FDA takes 'first step' toward greater regulatory certainty
14 June 2011
Japan lead under threat in global Ђ16.75bn functional foods market
14 June 2011
New 'alternative medicine' web portal is available for healthcare providers
7 June 2011
EU “General function” health claims under Article 13 - ban on rejected claims likely in 2012
7 June 2011
Food Safety Week (UK), 6 to 12 June 2011
5 June 2011
E-submissions for new medical devices
26 May 2011
Non European 'dot com' websites can be affected by the EU Herbal Directive
15 May 2011
GRS & Pilgrim Partner announcement
15 May 2011
Herbal News in Brief: GP-TCM in the post-genomic era
15 May 2011
Botanicals/Natural Products Meeting Report, Genesis 2010
15 May 2011
A fresh take on Traditional Medicine - University of Sydney
15 May 2011
UK regulation of herbal practitioners
15 May 2011
People warned over adulterated herbal weight loss pill
15 May 2011
8 March 2011: Bench to Boardroom Event, GRS to host roundtable workshop
15 May 2011
GRS to co-host Botanicals and Natural products stream as a pilot at Genesis 2009
15 May 2011
UKTI: Passport to Export Programme - GRS to present
15 May 2011
GRS to present at London Conference "Potent Substances: on the Boundaries of Food and Medicine", 13-15 September 2010
15 May 2011
GRS presents at London First Event "The Business of Healthcare in London", 25 May 2010
15 May 2011
Announcement: GRS to host Botanicals and Natural products Stream at Genesis 2010
15 May 2011
Overview and update on EU directive 2004/24/EC: Traditional herbal medicines (peer reviewed article)
15 May 2011
European and Non-European Paediatric Clinical Trials (peer reviewed article)
15 May 2011
Stem Cell Therapy Regulations: The US vs the EU (peer reviewed article)
15 May 2011
The Herbal Directive – is it the proverbial "sledgehammer to crack a nut"?
15 May 2011
Macmillan Cancer Support, Cambridge - programme of events
15 May 2011
Macmillan Cancer Support, Cambridge - programme of events
15 May 2011
Press Release: GRS and Macmillan Cancer Support Charity
15 May 2011
Press Release: Global Regulatory Services (GRS) and GlaxoSmithKline
15 May 2011
Natural Health Products: Challenges and Opportunities in the UK (Article)
15 May 2011
The European Herbal Directive: Friend or Foe? (Article)
15 May 2011
Press Release: Global Regulatory Services (GRS) and China
15 May 2011
Press Release: New Botanicals Stream announced ...
15 May 2011
Riding the Credit Crunch Rollercoaster (article)
15 May 2011
Nutraceuticals – Foods or Medicines? (Article)
15 May 2011
Can Stem Cell therapy become an integral part of our healthcare? (article)
15 May 2011
The Future of Herbal Medicines within Modern Society
15 May 2011
China: can traditional and modern medicinal products live in harmony? (Article)
15 May 2011
Children, Drugs and the EU Paediatric Initiative (article)
15 May 2011
"Britain is not on its knees" states Digby, Lord Jones of Birmingham (meeting report)
15 May 2011
Global Regulatory Services (GRS) - updated website
8 May 2011