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.

ABPI Extends Astellas UK Suspension for 12 More Months

The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."

Categories: Crisis management, Compliance, Ethics, News, Europe Tags: ABPI, Astellas, prescribing information
New Texas Law on Stem Cell Treatments: Showdown With FDA Coming?

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Categories: Human cell and tissue, Clinical, Ethics, Government affairs, News, US, FDA Tags: Texas stem cell treatments, stem cells
FDA Releases Annual Report on Biological Product Deviations

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers.

Categories: Biologics and biotechnology, Blood, Human cell and tissue, News, US, CBER Tags: Deviations, CBER
Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

Categories: Drugs, Medical Devices, Government affairs, Postmarket surveillance, News, Canada, Health Canada Tags: Health Canada, Vanessa's Law, adverse event reporting
FDA Revises Draft Guidance on Medical Gases

The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance detailing the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.

Categories: Compliance, Distribution, Labeling, Manufacturing, News, US, FDA Tags: Medical Gas
Regulatory Recon: Merck Hit in Global Ransomware Attack; Califf Shares Ideas on Real World Evidence (28 June 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
GAO: FDA Needs a Plan for GDUFA Carryover Fees

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO
House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017

The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration.

Categories: Due Diligence, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: FDA FY 2018, FDA budget, FDA appropriations
AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: Medical Devices, Crisis management, Government affairs, Postmarket surveillance, News, US, FDA Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)
Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

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, CFDA, CDSCO, TGA, ICH Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals
FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

Categories: Generic drugs, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: generic drugs, priority review of generics, drug price competition, drug prices
Regulatory Recon: Merck Cholesterol Drug Surprises With Phase III Success; Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 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 Offers New EudraVigilance Checklist for Sponsors, MAHs

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: EudraVigilance, marketing authorisation holders, individual case safety reports
Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: REMS, Generic Competition
FDA, NCI to Collaborate Further on Cancer Research

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: Combination products, Drugs, In vitro diagnostics, Medical Devices, Government affairs, News, US, CDRH Tags: National Cancer Institute, proteogenomics, cancer research
Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: Drugs, Medical Devices, Clinical, News, US, FDA Tags: CTTI, mobile technology and clinical trials, novel trial endpoints
FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

Categories: Biologics and biotechnology, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution
Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention Drug (26 June 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
Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA Tags: Brexit, EMA Relocation
EMA Recommends New HCV, Cancer and MS Drugs for Approval

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, Europe, EMA Tags: CHMP, Maviret, Vosevi, Imraldi
Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 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
Senate Health Bill Would Repeal Device Tax

Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law.

Categories: Medical Devices, Government affairs, News Tags: Medical Device Tax
European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance, News, Europe, EMA, MHRA Tags: European Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Warns Chinese API Maker for Data Integrity Issues

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, News, US, China, FDA Tags: Data Integrity
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