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.

Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, News, US, FDA Tags: Rob Califf, FDA commissioner, benefit-risk assessments, pharmaceuticals, medical devices
FDA Begins Accepting Regenerative Therapy Applications for RAT Designation

The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act making drugs eligible for designation as a regenerative advanced therapy (RAT).

Categories: Biologics and biotechnology, Drugs, Human cell and tissue, News, US, CBER Tags: RAT designation, regenerative therapy, cell therapy, OTAT
European Regulatory Roundup: The Netherlands Bids to Host EMA (20 January 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, Brexit
Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Combination products, Drugs, Human cell and tissue, Medical Devices, News, US, Canada, Europe, Asia, FDA, EMA, NICE, Health Canada Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report

With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials.

Categories: Drugs, Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Phase II trials, Phase III trials, pharmaceutical development, R&D
Politicizing the FDA: What the Trump Win Means for New Pharma Regulations

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Trump, FDA, FDA commissioner pick, Rob Califf
FDA Form 483 Cites 14 Observations for Zimmer Biomet

Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Warsaw, IN-based site with 14 observations.

Categories: Medical Devices, Compliance, Quality, News, US, FDA Tags: Zimmer Biomet, Form 483, CAPA
Updated: FDA and EMA in 2016: A Look at the Numbers

The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, Europe, FDA, EMA Tags: New active substances, New molecular entity, Approvals
Regulatory Recon: Trump Taps Lobbyist for FDA Role During Transition; Global Coalition Aims to Prevent Future Epidemics (19 January 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’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market.

Categories: Generic drugs, Labeling, News, US, FDA Tags: Jazz Pharmaceuticals, Xyrem, generic approvals
FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

Categories: Drugs, News, US, FDA Tags: Abuse Potential, Prescription Drug Abuse, Guidance
Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety.

Categories: Drugs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: foreign pharmaceutical inspections, FDA foreign offices, FDA in China, FDA and India
FDA Warns One Japanese, One Chinese Drugmaker

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, Quality, News, US, Japan, China, FDA Tags: Warning Letter, Data Integrity, Import Alert
CBER Announces Planned Guidance for 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research on Wednesday announced the guidance documents it plans to publish in 2017.

Categories: Biologics and biotechnology, Blood, News, US, CBER Tags: Guidance
Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: Crisis management, Compliance, Labeling, Regulatory strategy, Regulatory intelligence, News, US, FDA, Advertising and Promotion Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance
Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017)

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

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, News, China, India, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Drugmakers say New FDA Commissioner Should Have Medical Experience; Pharma Industry Reacts to UK PM May's Brexit Speech (18 January 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: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives; ANVISA Approves GW's Cannabis-Based Sativex (17 January 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 Issues Long-Awaited Biosimilar Interchangeability Guidance

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration, News, US, FDA Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study
FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging

The US Food and Drug Administration (FDA) last week finalized its guidance on repackaging drugs by pharmacies and registered outsourcing facilities and also issued a revised draft guidance detailing its policies on mixing, diluting and repackaging certain types of biological products outside of the scope of an approved biologics license application (BLA).

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags:
Drug Compounding With Bulk Substances: FDA Offers Interim Policies

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Quality, News, US, FDA Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy
EMA Reveals List of Eligible Industry Stakeholder Organizations

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

Categories: Government affairs, News, Europe, EMA, EC, Business and Leadership Tags: drug industry stakeholders
NICE Halts Plans to Charge for Appraisals

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Reimbursement, News, Europe, EMA, MHRA, NICE Tags: Brexit, UK Life Sciences, ABPI, NICE
Regulatory Recon: Trump Promises 'Insurance for Everybody'; FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 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 Further Explains Delay on LDT Guidance

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: lab-developed tests, LDTs, FDA on lab tests
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