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.

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Research and development, News, US, CDRH Tags: CDRH guidance, 510(k) alternative pathway, PMA
Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 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
Experts Look For Lessons in FDA's Pacemaker Cybersecurity Recall

In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable medical device.

Categories: Medical Devices, Postmarket surveillance, News, US, FDA, Communication Tags: Cybersecurity
IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme 

With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November.

Categories: Biologics and biotechnology, Drugs, News, US, Canada, Europe, Asia, ICH Tags: IGDRP, IPRF,
Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss

The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and projects, though whether PRVs have actually spurred new research remains a question.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: priority review voucher, neglected tropical disease, rare pediatric disease
Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.

Categories: Generic drugs, News, US, FDA Tags: ANDA amendments, FDA draft guidance
Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 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
Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 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
Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies.

Categories: Biologics and biotechnology, Drugs, Government affairs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: post-approval studies, research requirements, post-marketing research
FDA Backs Off From Regulating Certain Types of Health Software

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Research and development, News, US, FDA Tags: digital health, health software, 21st Century Cures
European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA, EC Tags: Brexit, PRAC, orphan drugs
FDA's Frey Reflects on Final Year of PDUFA V

As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI.

Categories: Biologics and biotechnology, Drugs, Orphan products, Submission and registration, News, US, CDER, Communication Tags: PDUFA, NDA, BLA, Orphan Drugs, Approvals
FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing.

Categories: Drugs, Preclinical, Regulatory intelligence, News, US, FDA Tags: toxicology, FDA toxicology working group
FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, US, FDA Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells
More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

Categories: Drugs, Clinical, News, US, FDA, EMA Tags: rare pediatric disease, Gaucher, FDA draft guidance
Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 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
Woodcock: CDER Informatics System is Top Priority for 2018

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Compliance, Submission and registration, News, US, CDER Tags: 21st Century Cures, Informatics, CDER
FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi, a parasite that causes Chagas Disease, in blood and blood components.

Categories: Blood, Compliance, News, US, CBER Tags: Chagas Disease, blood collection, FDA guidance
FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility

The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility.

Categories: Drugs, Crisis management, Ethics, Regulatory strategy, News, US, FDA Tags: Glenmark Pharmaceuticals, Form 483
NEST Seeks Medical Device Test Cases for Using Real World Evidence

The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices.

Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, Preclinical, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: NEST, NESTcc, real world data, real world evidence
FDA Warns California Device Company for Failing to Disclose Serious Injury

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

Categories: Medical Devices, Compliance, News, US, CDRH Tags: warning letter, device injury
Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

Categories: Clinical, Research and development, News, US, FDA Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan
Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, China, Oceania, CFDA, TGA Tags: transvaginal mesh, confidential information, medicine naming
Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 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
FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices

The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.

Categories: Medical Devices, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: CMS coverage of medical devices, FDA guidance
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