Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, News, US, China, FDA, APIs Tags: Data integrity, warning letter
Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance.

Categories: In vitro diagnostics, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Illumina, Roche, AstraZeneca, next-gen sequencing, infectious disease diagnostics
Regulatory Recon: Kite Looks to File CAR-T Application; FDA Approves J&J's Stelara for Crohn's (27 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance
Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Drugs, Medical Devices, News, Asia, MHLW, CFDA, CDSCO Tags: Asia Regulatory Roundup, DCGI, China medical devices, CFDA enforcement
EMA and FDA Set Up New Working Group on Rare Diseases

The new collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced Monday will improve the sharing of information on various aspects of the development and scientific evaluation of medicines for rare diseases.

Categories: Drugs, Government affairs, News, US, Europe, FDA, EMA Tags: rare disease, FDA and EMA collaboration, rare disease cluster
Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples

The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in the development of FDA-approved new molecular entities and new biologics.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, FDA Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers
GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.

Categories: Generic drugs, Compliance, Government affairs, Manufacturing, News, US, FDA Tags: ANDA backlog, generic drug reviews, generic competition
CDSCO Advances Draft Medical Device Rules, Outlines Fees

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.

Categories: Medical Devices, News, India, CDSCO Tags: Fees, Draft Medical Device Rules 2016
Regulatory Recon: Pfizer Decides Not to Split; Regeneron Gets Priority Review for Eczema Drug (26 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible.

Categories: Medical Devices, News, FDA, ISO Tags: ISO 13485:2016
Regulatory Recon: States Allege Indivior Tried to Block Generic Competition for Suboxone; Novartis' Zykadia Successful in Lung Cancer Phase III (23 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Approves First Humira Biosimilar

The US Food and Drug Administration (FDA) on Friday announced it had approved Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's best-selling biologic Humira (adalimumab).

Categories: Biologics and biotechnology, Submission and registration, News, US, FDA Tags: Humira, Amjevita, Biosimilar, adalimumab, adalimumab-atto
Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

Congress and President Barack Obama have one week to reauthorize the pediatric priority review voucher (PRV) program, which will sunset on 30 September 2016 after seven pediatric PRVs have been awarded, one of which sold for $350 million last year.

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags: priority review vouchers, PRV, pediatric PRV, Sarepta, Janssen, Alexion
Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction; Alzheimer’s Drug Fails in Phase III Study (22 September 2016)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Medical Devices, News, US, Canada, Europe, Asia, FDA, EMA, EC, MHRA, NICE Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

Categories: Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: biosimilar, interchangeability, BsUFA
FDA Finalizes Guidance on Generic Drug Facility Self-Identification

The US Food and Drug Administration (FDA) on Thursday finalized guidance on information regarding what companies need to self-identify as a producer of generic drugs and what information they must provide to FDA.

Categories: Active pharmaceutical ingredients, Generic drugs, Government affairs, Manufacturing, News, US, FDA Tags: GDUFA, generic facility self-identification, FDA guidance
European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016)

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

Categories: Biologics and biotechnology, Drugs, News, EMA, EC, MHRA Tags: EU, antibiotics, HTA, marketing authorisation
Regulatory Recon: Genentech Bets $310M on Cancer Vaccine Tech; Global Pledge on Superbugs (21 September 2016)

Welcome to Regulatory Reconnaissance. Today’s edition comes to you as the Focus team returns from Regulatory Convergence. Hope you had a good conference.

Categories: Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
CDRH Outlines Top 10 Science Priorities for 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for more regulatory decisions, according to a list of its science priorities for 2017.

Categories: In vitro diagnostics, Medical Devices, News, US, CDRH Tags: CDRH, device priorities, real-world data for devices
Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Biologics and biotechnology, Drugs, Government affairs, Manufacturing, News, Asia, PMDA, CFDA, TGA Tags: Thai FDA, Skynet, Australia expedited pathways, CFDA on generics
Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals

With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told Focus in an exclusive interview.

Categories: Biologics and biotechnology, Drugs, News, US, Latin America and Caribbean, FDA, EMA, ICH, WHO Tags: Cuba, Cuba embargo, lung cancer vaccine Cuba, Cuba drug regulations
Regulatory Recon: Allergan to Buy Tobira in $1.7b Deal; GSK Names Emma Walmsley as New CEO (20 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Sarepta Wins Controversial FDA Approval for First DMD Drug

The US Food and Drug Administration (FDA) on Monday approved Sarepta Therapeutics’ first drug to treat patients with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness in young children.

Categories: Drugs, News, US, FDA Tags: Sarepta Therapeutics, DMD, eteplirsen, FDA approval of DMD drug
EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's

Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research.

Categories: Biologics and biotechnology, Drugs Tags: Alzheimer's Disease, Data Sharing
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