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.

'Right to Try' Legislation Tracker

Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.

Categories: Clinical, Ethics, Government affairs, News, US, CDER Tags: Right to Try, Right-to-Try, Compassionate Use, Expanded Access
Regulatory Recon: The President's Plan to Combat Antibiotic Resistance (27 March 2015)

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
European Regulatory Roundup: European Regulators, Industry Focused on New Trade Agreement (26 March 2015)

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

Categories: Regulatory intelligence, News, Europe, EMA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
FDA Advisory Committee Calendar

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees
UK Regulator Touts its Involvement in Domestic Manufacturing Site

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is once again touting its efforts to bolster manufacturing innovation, releasing a case study explaining its role in the redevelopment of a local manufacturing site.

Categories: Combination products, Government affairs, Manufacturing, Regulatory strategy, News, Europe, MHRA Tags: Innovation Office
Trial Lawyers, Favoring FDA's Generic Drug Labeling Rule, Blast Generic Drug Industry Study

A trade group representing trial lawyers is fighting back against a 2014 report by the generic pharmaceutical industry which claimed a rule proposed by the US Food and Drug Administration (FDA) to allow generic drug companies to help update drug labels could cost the industry billions and raise drug costs for consumers.

Categories: Generic drugs, Labeling, News, US, CDER Tags: Generic Drug Labeling Rule, American Association for Justice, Trial Lawyers, Generic Drug Labeling
Regulatory Recon: FDA Approves New Vaccine, Eye Drug (26 March 2015)

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
UK Regulators Prepare for Review of 'Forgotten Thalidomide'

Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages.

Categories: Drugs, Government affairs, Postmarket surveillance, Product withdrawl and retirement, News, Europe, MHRA Tags: Primodos, Duogynon, Hormonal Pregnancy Tests, Thalidomide
Health Canada to Stop Accepting Hard Copies of Class III, IV MDL Application and Fee Forms

Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting 1 April 2015, and will also require a separate fee form to be electronically submitted with application forms starting on that same date.

Categories: Medical Devices, Submission and registration, News, Health Canada Tags: Emergo, Emergo Group
FDA Plans Studies into Problems Affecting Complex Generic Drugs

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing to fund studies to develop models to better evaluate generic drugs, including modified-release drugs and several popular oral anticoagulants.

Categories: Generic drugs, News, US, CDER Tags: Office of Generic Drugs
FDA's Electronic Drug Labeling Proposal Comes Under Fire

The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk.

Categories: Biologics and biotechnology, Drugs, Labeling, News, US, CDER Tags: Electronic Drug Labeling Rule, Package Insert, Electronic Labeling, Proposed Rule, Proposed Regulation, FDA Regulation
Regulatory Recon: FDA's New Approach to Facility Inspections (25 March 2015)

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
Bill Would Make Permanent FDA's Rare Pediatric Voucher Program

New legislation introduced this week would reauthorize the US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program, which is currently set to end after triggering a sunset clause in its authorizing statute.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, News, US, CDER Tags: Priority Review Voucher, Advancing Hope Act, Rare Pediatric Disease Priority Review Voucher
Pakistani Government Publishes New Medical Device and IVD Registration Rules

Pakistan’s Drugs Regulatory Authority has issued new medical device and in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules 2015, which have gone into effect.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, Asia Tags: Emergo, Pakistan
Asia Regulatory Roundup: Chinese, Indian Regulators Plan Major Digital Initiatives (24 March 2015)

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

Categories: Regulatory intelligence, News, Asia, Oceania Tags: Asia Regulatory Roundup, Regulatory Roundup
FDA Legislation Tracker

Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, News, US, FDA Tags: FDA Legislation Tracker, Legislation, Bill, House, Congress, President, FDA Legislation, FDA Bill
Should FDA Make Changes to the Way it Regulates Homeopathic Products? Agency Wants to Know

The US Food and Drug Administration (FDA) regulates many types of products—drugs, medical devices, cosmetics, food, lasers and tobacco among them. But you'd be forgiven if you forgot the agency regulates another type of medicine: homeopathy. Now FDA wants to know if its regulatory framework for regulating homeopathic products is adequate, and whether changes are needed.

Categories: News, US, FDA Tags: Homeopathy, CPG 400.400
Regulatory Recon: FDA on Pace to Match Drug Approval Records (24 March 2015)

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
Indian Court Sides with Merck in Patent Dispute

A prominent court in India has issued an interim injunction, overturning a previous ruling, in favor of US drug maker Merck in a patent dispute with Glenmark Pharmaceuticals over an active ingredient used in two of Merck's diabetes medicines, Januvia and Janumet.  

Categories: Active pharmaceutical ingredients, Drugs, Regulatory strategy, News, India Tags: Intellectual Property, Patents, Delhi High Court, Merck, Glenmark, Januvia
Last Week in Focus: Updates to our Regulatory Trackers and Explainers (23 March 2015)

Here at Regulatory Focus, we don't just write about the latest regulatory news and events—we keep track of them, too. Each week, we update several of our "Regulatory Trackers" and "Regulatory Explainers," all in the hopes of making it easier for you to make sense of complex regulatory developments. Make sure you didn't miss a thing by reading this at-a-glance update.

Categories: News Tags:
Are Biotechnology Products Safe for the Environment? FDA's New Policy Asks for Data

While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment.

Categories: Biologics and biotechnology, Compliance, News, US, CBER Tags: Guidance, Final Guidance, GTVV, gene therapies, vectored vaccines, related recombinant viral products, related recombinant microbial products
The Tip of the Iceberg: What Lurks Beneath the 483

At the end of a grueling week spent sitting in a conference room with an investigator from the US Food and Drug Administration (FDA), you may end up with an FDA Form 483 listing the inspectional observations that the agency has cited as potentially deficient.

Categories: Audit, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: RIQ, Regulatory Intelligence Quotient, Graematter, FDA Form 483, Form 483, EIR, Establishment Information Report
Regulatory Recon: Is it Time to Reform FDA's Device Approval Process? (23 March 2015)

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
Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs

The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, the agency announced this week.

Categories: Drugs, News, US, FDA Tags: HIV, AIDS, Advisory Committee, AdComm, Antiviral Drugs Advisory Committee, Anti-viral Drugs Advisory Committee
FDA Finalizes Lot Distribution Report Guidance With Few Changes

New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed.

Categories: Biologics and biotechnology, Compliance, Postmarket surveillance, News, US, CDER Tags: Guidance, Final Guidance, LDR, Lot Distribution Reports, BLA
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