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.

Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.

Categories: Drugs, In vitro diagnostics, Labeling, News, US, FDA Tags: Antimicrobial Susceptibility Interpretive Test Criteria, Breakpoint, 21st Century Cures
Medtronic Settles Deceptive Advertising Lawsuit for $12M

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multistate settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse.

Categories: Medical Devices, News, US, Advertising and Promotion Tags: Medtronic, Infuse, deceptive marketing
Generic Drug Monthly Dashboard: FDA Adds New Metrics

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.

Categories: Generic drugs, News, US, FDA Tags: generic drug activity, GDUFA II
Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 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 Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

Categories: Over the counter drugs, Quality, News, US, Asia, FDA Tags: Coko Loko, Legal Lean Syrup, Seindni
FDA Issues Draft Guidance on Gluten Labeling for Drugs

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten.

Categories: Drugs, News, FDA Tags: Gluten, Gluten-Free, Labeling
CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, News, CDRH Tags: patient-reported outcomes, medical device submissions
Congress Looks to Delay Medical Device Tax by 5 Years

The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018.

Categories: Medical Devices, Government affairs, News, US Tags: device tax, AdvaMed
Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

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

Categories: Drugs, Compliance, Government affairs, News, Asia, Oceania, TGA Tags: Asia Regulatory Roundup, ACSS, GSK, Novartis
When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: Biologics and biotechnology, Drugs, Compliance, Due Diligence, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: refuse to file, NDA, BLA, FDA draft guidance
Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 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 on Promotional Drug Labeling and Ads

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: Drugs, News, US, FDA, Advertising and Promotion Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads
French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, News, Europe, EMA Tags: First-in-Human, Clinical Trials, ANSM, Bial
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
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