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.

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
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
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
Regulatory Recon: Drugmakers Fought State Opioid Limits; FDA Approves Sarepta DMD Drug (19 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
Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research this week issued final guidance for investigation new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early-phase clinical trials.

Categories: Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, CBER Tags: gene therapies, FDA guidance, IND guidance
Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via ClinicalTrials.gov, though it remains to be seen if the $10,000 per day penalties from the US Food and Drug Administration (FDA) will be strictly enforced.

Categories: Biologics and biotechnology, Drugs, Clinical, Compliance, News, US, FDA Tags: clinical trials, final NIH rule, clinical trial transparency, FDA penalties, clinicaltrials.gov
Regulatory Recon: EMA Recommends 11 Drugs for Approval, Including Cancer Drugs From Lilly, Pfizer and Takeda (16 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, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EMA’s CHMP Recommends Ban of US CMO’s Medicines

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) should no longer be available in the EU, except for Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health.

Categories: Drugs, Crisis management, Government affairs, Manufacturing, Quality, News, US, Europe, FDA, EMA, EC, MHRA Tags: Pharmaceutics International, CHMP, US contract manufacturing of drugs
FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo

The US Food and Drug Administration (FDA) this week agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications for renal cell carcinoma, metastatic melanoma and non-small cell lung cancer. 

Categories: Biologics and biotechnology, Drugs, Compliance, Due Diligence, Labeling, News, US, FDA Tags: Opdivo, Bristol-Myers Squibb, Opdivo dosing
Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials

The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD).

Categories: Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: ADPKD, biomarkers, FDA qualification of biomarkers
New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10%

US Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ), as well as Rep. Jan Schakowsky (D-IL), on Thursday introduced new bills that would require drug manufacturers to disclose and provide more information about planned drug price increases, as well as data on research and development costs.

Categories: Drugs, Government affairs, News, US, FDA Tags: drug prices, Schakosky, Tammy Baldwin, John McCain, drug price transparency
Regulatory Recon: FDA Panel Narrowly Supports Removing Chantix Boxed Warning; FDA Approves New Heart Drug Yosprala (15 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
European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016)

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

Categories: Drugs, Clinical, Government affairs, Manufacturing, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, Brexit, adaptive pathways, Emer Cooke
« 1 2 3 4 5  ... »