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.

Public Citizen Sues FDA Over OTC Drug Risks

Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine.

Categories: Over the counter drugs, News, US, FDA Tags: Benzocaine, Teething, Methemoglobinemia, Public Citizen, OTC Monograph
FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

Categories: Biologics and biotechnology, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: biosimilar guidance, analytical similarity, FDA guidance
Regulatory Recon: EU Approves Merck, Pfizer's Bavencio; FDA Advises on Opioid Benzo Combo (21 September 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 Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: EU ombudsman, early regulator engagement, pre-submission meetings
European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017)

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

Categories: Biologics and biotechnology, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, MHRA Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines
Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars

Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance on the US market for its blockbuster Remicade (infliximab) despite recently introduced competition.

Categories: Biologics and biotechnology, Compliance, News, US, FDA Tags: Pfizer, J&J, infliximab, Remicade, Inflectra, Renflexis
FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

Categories: Biologics and biotechnology, Drugs, Clinical, Ethics, News, US, FDA Tags: Expanded Access, Compassionate Use, Right-to-Try
Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: Generic drugs, Compliance, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: REMS, Hatch-Waxman, generic drug competition
FDA's Woodcock: The Clinical Trials System is 'Broken'

The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, US, FDA, ICH Tags: Janet Woodcock, real world evidence, real world data, drug development
Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 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
Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017)

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

Categories: Drugs, Medical Devices, News, Asia, CFDA, TGA Tags: Asia Regulatory Roundup
Real World Evidence: FDA Commits to Advancing its Use

To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, News, US, FDA Tags: real world evidence, Scott Gottlieb, clinical data
UK’s MHRA Unveils Human Factors Guidance for Medical Devices

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: Combination products, In vitro diagnostics, Medical Devices, Government affairs, News, Europe, EC, MHRA Tags: human factors guidance for medical devices, MHRA guidance, MDR
Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, News, US, FDA Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures
FDA Warns Korean, Chinese Drugmakers

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

Categories: Drugs, Manufacturing, News, US, Asia, FDA Tags: FDA warning letters, Wuxi Medical, Firson
Regulatory Recon: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 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 Finds No Difference in Inhibitor Risk Between Factor VIII Classes

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.

Categories: Biologics and biotechnology, Blood, News, Europe, EMA Tags: Factor VIII, Inhibitor, Hemophilia A
Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 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
Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors.

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags: Quantitative Benefit-Risk Assessment, ICH M4E(R2)
Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

Late last month, Malaysia’s government issued a compulsory license in an effort to offer a less-expensive version of Gilead’s hepatitis C drug and increase access.

Categories: Drugs, News, Asia Tags: Malaysia, Gilead, Hepatitis C, compulsory license
FDA Offers Draft Guidance on Organ Preservation Device Animal Studies

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

Categories: Medical Devices, Clinical, News, US, CDRH Tags: organ preservation, FDA draft guidance
Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 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
House Reps Seek More Transparency on Novartis-CMS Pricing Deal for Newly Approved CAR-T Therapy

Rep. Lloyd Doggett (D-TX) and other House Democrats on Wednesday sent a letter to Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), seeking to find out more information about an outcomes-based payment approach for Novartis’ newly approved chimeric antigen receptor T-cell (CAR-T) treatment Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: Compliance, Reimbursement, News, US Tags: CAR-T, outcomes-based deal, Novartis
FDA Finalizes HPV Diagnostic Study Guidance

The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer.

Categories: In vitro diagnostics, News, US, FDA Tags: HPV, Human Papillomavirus, Cervical Cancer
FDA Steps in to Regulate Microneedling Devices

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation.

Categories: Medical Devices, Submission and registration, News, US, FDA Tags: Microneedling, Micro-needling, Draft Guidance
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