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.

Japan Launches NIH Analogue

Today marks the launch of Japan’s new Agency for Medical Research and Development (AMED), which will take on the role of leading research and development in the country through partnerships between universities and industry.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Orphan products, Government affairs, Preclinical, Research and development, Regulatory strategy, News, Japan, MHLW, PMDA Tags: AMED, Agency for Medical Research and Development
FDA Finalizes Approach to Abuse-Deterrent Opioids

Federal regulators have at long last finalized a policy which establishes voluntary guidelines by which manufacturers of opioid-based painkillers can prove that their products are resistant to misuse and abuse by patients.

Categories: Drugs, Clinical, Labeling, Postmarket surveillance, News, US, CDER Tags: Opioids, Abuse-Deterrent Opioids, Guidance, Final Guidance
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
Does FDA Need New Authority to Regulate Complex Generic Drugs?

New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority.

Categories: Generic drugs, News, US, CDER Tags: Bill, Congress, Legislation, Generic Complex Drugs Safety and Effectiveness for Patients Act, Nonbiologic Complex Drugs, Complex Generic Drugs
'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: Group Calls on FDA to Crack Down on Diabetes Drug Marketing (1 April 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
Asia Regulatory Roundup: Medical Device Issues Take Center Stage for India, Pakistan and Asia (31 March 2015)

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

Categories: Regulatory intelligence, News, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
EU Regulators Reveal 'Strategy to 2020'

European medicines regulators are asking for feedback on a newly released plan intended to lay out the European Medicines Agency (EMA) and the Heads of Medicines Agencies’ (HMA) strategic direction for the next five years.

Categories: Government affairs, News, Europe, EMA, EC, Communication Tags: EU medicines agencies network, Heads of Medicines Agencies, 2020
What you Need to Know About Meeting With FDA's Medical Device Advisory Committee

For many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances at a timely approval.

Categories: Medical Devices, Regulatory strategy, News, US, CDRH Tags: Guidance, Draft Guidance, MDAC, Medical Device Advisory Committee, AdComm, Advisory Committee
FDA Considers Relaxing Clinical Testing Requirements for Some Biotherapeutic Products

The US Food and Drug Administration (FDA) is considering making it easier for companies to test certain "live biotherapeutic products" like probiotics in early-stage trials, the agency has announced.

Categories: Biologics and biotechnology, Nutritional and dietary supplements, Clinical, Manufacturing, News, US, CBER Tags: Guidance, Final Guidance, LBPs, Live Biotherapeutic Products, Dietary Supplement
Regulatory Recon: Europe's New Five-Year Drug Regulatory Strategy (31 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
Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance

A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI).

Categories: Drugs, Clinical, News, US, FDA Tags: Guidance, Final Guidance, CPI, Critical Path Initiative, Drug Innovation, Innovation, Critical Path Innovation Meetings
EMA Gives Details on New Elemental Impurity Guideline

The European Medicines Agency (EMA) has released its recommendations for implementing a newly adopted international standard for limiting elemental impurities in drug products.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Quality, News, Europe, EMA, ICH Tags: ICH, Q3D, Step 4, Elemental Impurities
Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave

The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed.

Categories: Generic drugs, News, US, CDER Tags: OGD, Office of Generic Drugs, Kathleen Uhl
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
Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks.

Categories: Drugs, Labeling, News, US, CDER Tags: Generic Drug Labeling, Generic Drug Safety, Expedited Agency Review, EAR, PhRMA, GPhA
UK Regulators Detail Most Common Pharmacovigilance Deficiencies in New Report

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has released statistics on the pharmacovigilance inspections it conducted between April 2013 and March 2014. While the figures continue a similar trend from previous years, MHRA says the impact of new EU pharmacovigilance legislation can be seen in the data.

Categories: Drugs, Postmarket surveillance, Regulatory strategy, News, Europe, MHRA Tags: Pharmacovigilance, inspections, GPvP
FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality

New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products.

Categories: Active pharmaceutical ingredients, Drugs, Manufacturing, Quality, News, US, CDER Tags: Draft Guidance, Guidance, NIR, Near Infrared, ICH Q2 (R1)
Regulatory Recon: In Farewell Speech, Hamburg Skeptical of Congressional Reform Efforts (30 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
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
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
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