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.

Regulatory Recon: FDA Warns of Severe Joint Pain With DPP-4 Inhibitors (31 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

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: FDA Spells Out Biosimilar Naming Rules, Second PCSK9 Inhibitor Approved (28 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
European Regulatory Roundup: EMA Posts Recommendations on Advanced-Therapy Medicinal Product Classifications (27 August 2015)

The European Medicines Agency (EMA) has updated its list of summaries of recommendations on the classification of advanced-therapy medicinal products (ATMPs). Melanoma-derived lymphocytes, allogeneic cord blood cells and other forms of ATMPs are discussed in the newly-added documents. 

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
FDA Issues Long-Awaited Biological Product Naming Guidance

Today, the US Food and Drug Administration (FDA) released its long-awaited guidance establishing a naming convention for biologicals, including related and biosimilar products.

Categories: Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Submission and registration, News, US, FDA Tags: Biosimilars, related biological products, naming convention, biological qualifier, suffix
Regulatory Recon: FDA Responds to Congress on Opioid Black Boxes (27 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Are You a Good Witch, or a Bad Witch?

Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a good witch, or a bad witch?” As we soon learn in the film, this is a critical distinction—Glinda helps Dorothy return home to Kansas, while the Wicked Witch of the West uses every resource she has, including those terrifying flying monkeys, to capture Dorothy and her ruby slippers. We considered this question relative to the Refuse to Accept Policy for 510(k)s from the US Food and Drug Administration (FDA).

Categories: Medical Devices, Submission and registration, Articles, News, US, CDRH Tags: US Food and Drug Administration, FDA, medical device, refuse to accept policy, RTA, 510(k), premarket clearance
Canada's Medical Marijuana Regulations, An Overview

This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers.

Categories: Articles, Features, Canada, Health Canada Tags: marijuana, medical marijuana, Canada, Health Canada
Regulatory Recon: FDA Gives Industry More Time to Comment on Quality Metrics (26 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Quality Metrics: Industry Reaction to FDA's Draft Guidance

On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July.

Categories: Biologics and biotechnology, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory strategy, News, US, FDA Tags: Quality metrics, Inspections, Office of Pharmaceutical Quality, PhRMA, GPhA
Asia Regulatory Roundup: Australia Recommends First Pharmacy-Level Substitution of mAb Biosimilar (25 August 2015)

Officials in Australia have set the stage for a pair of firsts by registering a biosimilar monoclonal antibody (mAb) and recommending it for pharmacy-level substitution. The decisions mean Hospira's Remicade copy is set to be both Australia's first biosimilar mAb and its first substitutable biological copycat.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Japan, China, India, Oceania, PMDA, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Medical Device Task Force Releases Recommendations for National Evaluation System (25 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FTC Asks FDA to Reevaluate Framework for Homeopathic Products

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient.

Categories: Over the counter drugs, Labeling, News, US, FDA, FTC, Advertising and Promotion Tags: Federal Trade Commission, FTC, Homeopathy, Homeopathic
Regulatory Recon: Sarepta, BioMarin Chase Priority Voucher After AbbVie Drops $350 Million on One (24 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
What Causes Variations in Review at CDER? It's All About the Designation

Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA Tags: Accelerated review, priority review, fast-track designation, breakthrough therapy designation, CDER
Regulatory Recon: Is FDA 'Basically Approving Everything' or Do the Numbers Tell a Different Tale? (21 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

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 Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

Categories: Drugs, Government affairs, Research and development, News, US, FDA Tags: Antimicrobial resistance, AMR, Antibiotic resistance, NARMS
European Regulatory Roundup: Commission Posts Draft of Key Falsified Medicines Directive Regulation (20 August 2015)

The European Commission has released draft rules for the implementation of safety features as part of its preparations for the rollout of the Falsified Medicines Directive (FMD).

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA, NICE Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
Regulatory Recon: AbbVie Buys Priority Review Voucher for Record Breaking $350 Million (20 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

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 Pushes GUDID Compliance Back for Some Devices Due to Security Flaw

After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements.

Categories: Medical Devices, Labeling, News, US, FDA Tags: GUDID, Global Unique Device Identification Database, Unique Device Identification
Regulatory Recon: FDA Approves Female Libido Drug Addyi, With a Boxed Warning (19 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

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 to Explore Criteria for Quarterly Medical Device Malfunction Reporting

The US Food and Drug Administration (FDA) has announced it will pilot a new initiative to explore criteria for allowing medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis.

Categories: Medical Devices, Postmarket surveillance, News, US, FDA Tags: Malfunction reporting
Asia Regulatory Roundup: Pakistani Manufacturers Shut Down in Protest Against Regulatory Amendment (18 August 2015)

Members of the Pakistan Pharmaceutical Manufacturers Association (PPMA) have shut down their units in protest against regulatory changes. The actions were later postponed following the death of a politician, but PPMA still has grievances with government plans to hand out 10-year prison terms for manufacturers of substandard medicines.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Japan, China, Taiwan, Korea, India, Asean, Oceania, PMDA, CFDA, CDSCO Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Scope Makers Fujifilm, Hoya and Olympus Warned for Testing and Reporting Issues (18 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
New FDA Guidance Addresses Common Issues in Orphan Drug Development

The US Food and Drug Administration (FDA) has released a draft guidance intended to help drugmakers tackle common issues encountered in the development of drugs to treat rare diseases.

Categories: Biologics and biotechnology, Drugs, Orphan products, Clinical, Preclinical, Research and development, Regulatory strategy, News, US, FDA Tags: Orphan drugs, Guidance documents
Regulatory Recon: FDA Approves Second Ever Opioid for Use in Children (17 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
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