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.

Will FDA Add Suffixes to Approved Biologics' Names?

Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: Biologics and biotechnology, News, US, FDA Tags: biosimilars, biosimilar naming
First Implementing Act Under EU MDR, IVDR Open for Consultation

The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.

Categories: In vitro diagnostics, Medical Devices, News, Europe, EC Tags: MDR, IVDR, medical device regulations Europe
EMA, European Commission Look to Foster Development of Advanced Therapies

The European Medicines Agency (EMA) and European Commission on Friday published a joint action plan to further the development of new cell and gene therapies, as well as other advanced therapy medicinal products (ATMPs).

Categories: Biologics and biotechnology, Human cell and tissue, Government affairs, News, Europe, EMA, EC Tags: ATMPs, gene therapy EU
Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, US, Europe, FDA, EMA, NICE Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: Biologics and biotechnology, Labeling, Postmarket surveillance, News, US, Europe, Asia, WHO Tags: biological qualifier, biosimilar naming
European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EC Tags: Supplementary Protection Certificate, Bolar exemption, research exemption, pharmaceutical patents
FTC Seeks Comments on Competition in Prescription Drug Markets

Ahead of a November workshop in which FDA Commissioner Scott Gottlieb will give a keynote address, the Federal Trade Commission (FTC) is seeking comments on a variety of questions related to competition issues in the US prescription drug market.

Categories: Drugs, Crisis management, Distribution, Regulatory strategy, Regulatory intelligence, News, US, FTC, Business and Leadership Tags: FTC on drug prices
European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017)

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

Categories: Drugs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, MHRA Tags: Brexit, HPV vaccine, CHMP
Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA, EC Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

Categories: Drugs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, CDER Tags: FDA guidance, product-specific guidance, generic drug guidance
FDA Analyst Counters Critiques of Orphan Drug Act

While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act, Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended.

Categories: Biologics and biotechnology, Drugs, Orphan products, News, FDA Tags: Orphan Drugs, Orphan Drug Act
Updated FDA Manual Offers Inside Look at Inspection Protocols

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: FDA inspections, contamination, sterile environments
Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Reimbursement, News, US, India, MHLW Tags: stents, knee implants, India price ceilings, medical devices in india
Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, stem cells, black triangle
ICH Transparency: New Info on Funding, Expert Working Groups

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, ICH Tags: ICH funding, E9, E11, S5
Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: Drugs, Reimbursement, News, US Tags: pharmaceutical pricing, Senate HELP committee, PhRMA
FDA Officials Offer Advice on Efficient Orphan Drug Development

A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.

Categories: Biologics and biotechnology, Drugs, Orphan products, Clinical, News, US, FDA Tags:
Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EMA Plots Out Priorities to Deal With Brexit Uncertainties

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: Biologics and biotechnology, Drugs, Crisis management, Postmarket surveillance, News, Europe, EMA, EC Tags: Brexit, EMA business continuity
Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to pay to transfer the patents to a Native American tribe and prolong the launch of Restasis generics.

Categories: Biologics and biotechnology, Drugs, Due Diligence, Government affairs, News, US Tags: Restasis, Allergan, Saint Regis Mohawk Tribe
Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

Categories: Medical Devices, Clinical, News, US, FDA Tags: Patient Engagement, PEAC
Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: Biologics and biotechnology, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM
Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee; GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EMA Revises Reflection Paper on Pediatric Extrapolation

The European Medicines Agency (EMA) on Friday released an updated draft reflection paper for public consultation detailing the agency's framework for pediatric extrapolation in drug development.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, News, EMA, ICH Tags: Pediatric Extrapolation
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