Search Results for EMA and FDA

Showing 1 – 25  of 243

EMA and FDA to Begin Sharing Commercially Confidential Information By Zachary Brennan - Published 23 August 2017

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will now share non-public and commercially confidential information, including trade secret information.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments By Zachary Brennan - Published 03 July 2017

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EMA and FDA, Gaucher disease, rare pediatric disease

European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017) By Nick Paul Taylor - Published 20 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, FDA, MHRA, Biologics and biotechnology, Drugs

Tags: European Regulatory Roundup, EMA and FDA, EudraVigilance, information security

US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections By Zachary Brennan - Published 02 March 2017

After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

Categories: News, Europe, US, EC, EMA, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, EMA and FDA initiatives, mutual recognition agreements, US-EU international agreement

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee By Zachary Brennan - Published 03 December 2015

The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals.

Categories: News, Europe, US, EMA, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Research and development

Tags: EMA, Califf, FDA, FDA commissioner, Xarelto, Bayer

Regulatory Recon: EU's Clinical Trial Regulation is Here (29 May 2014) By Alexander Gaffney, RAC - Published 29 May 2014

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Categories: News, EMA, FDA, Regulatory intelligence

Tags: EMA News, FDA News, Links, Regulatory, Regulatory News, Regulatory Reconnaissance

Regulatory Reconnaissance: Will EU Adaptive Licensing Changes Mean Less Market Exclusivity? (14 May 2014) By Alexander Gaffney, RAC - Published 14 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: FDA Dials Back on Use of REMS (13 May 2014) By Alexander Gaffney, RAC - Published 13 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Mind-Controlled Prosthetic Obtains FDA Approval (12 May 2014) By Alexander Gaffney, RAC - Published 12 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Merck's Zontivity Approved by FDA (9 May 2014) By Alexander Gaffney, RAC - Published 09 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Senate to FDA: What's up With These Draft Guidances? (8 May 2014) By Alexander Gaffney, RAC - Published 08 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: FDA Tests Blood Pressure Pills, Citing Concerns About Generics (7 May 2014) By Alexander Gaffney, RAC - Published 07 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: AZ's Heart Drug Epanova Wins FDA Approval (6 May 2014) By Alexander Gaffney, RAC - Published 06 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: FDA Smacks Down Aspirin Claims (5 May 2014) By Alexander Gaffney, RAC - Published 05 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: The Criminal Enterprise Behind Counterfeit Cancer Drugs (2 May 2014) By Alexander Gaffney, RAC - Published 02 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Watchdog Sues FDA Over GERD Drug (1 May 2014) By Alexander Gaffney, RAC - Published 01 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Breakthrough Pathway Leads to Speedy Approval for Novartis (30 April 2014) By Alexander Gaffney, RAC - Published 30 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Politicians Pressure FDA on Pain Pill Approval (29 April 2014) By Alexander Gaffney, RAC - Published 29 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: CHMP Recommends Six New Drugs (28 April 2014) By Alexander Gaffney, RAC - Published 28 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: The Jaw-Dropping Violations That Got Sun Pharma Banned (25 April 2014) By Alexander Gaffney, RAC - Published 25 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: FDA, EMA Working on Biosimilar Data Guidance (24 April 2014) By Alexander Gaffney, RAC - Published 24 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: AdComm Pans MoxDuo as Massachusetts Limits Zohydro (23 April 2014) By Alexander Gaffney, RAC - Published 23 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Lilly's Potential Blockbuster Gets FDA Approval (22 April 2014) By Alexander Gaffney, RAC - Published 22 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Hamburg Hits Back at Zohydro Criticism (21 April 2014) By Alexander Gaffney, RAC - Published 21 April 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory