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.

Bioethics Council Calls for Reforms for Clinical Trials Involving Children

The Nuffield Council on Bioethics has released a report on the ethical issues surrounding clinical research involving children in the UK and EU.

Categories: Clinical, Research and development, Regulatory strategy, News, Europe Tags: Children, Clinical trials, Pediatric, Paediatric investigation Plan
World Health Assembly Adopts Action Plan on Antimicrobial Resistance

In Geneva Monday, members of the World Health Assembly (WHA) endorsed a plan to fight antimicrobial resistance (AMR) on a global scale.

Categories: Drugs, Distribution, Labeling, Research and development, Regulatory strategy, News, WHO, Advertising and Promotion Tags: Antimicrobial resistance, AMR, WHA68, World Health Assembly
EMA Maintains Recommendation to Suspend Drugs for Data Integrity Issues

The European Medicines Agency (EMA) has reconfirmed its recommendation to suspend the authorization of medicines that relied on clinical studies performed by Indian contract research organization GVK Biosciences.

Categories: Active pharmaceutical ingredients, Generic drugs, Clinical, Ethics, News, Europe, India, EMA, EC Tags: GVK Biosciences, data integrity
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
FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week.

Categories: Biologics and biotechnology, Drugs, Packaging, News, US, FDA Tags: FDC, Fixed-Dose Combination, Unified Agenda, Co-Packaged Drugs, Co-Packaged Biologics, Regulation, Proposed Rule, Final Rule
Regulatory Recon: 21st Century Cures Act Unanimously Approved by House Committee (22 May 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
EMA Issues New Guideline on Gene Therapy

The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies.

Categories: Biologics and biotechnology, Human cell and tissue, Clinical, Preclinical, Quality, Regulatory strategy, News, Europe, EMA, ICH Tags: Gene therapy, Advanced therapy medicinal product, ATMP, Glybera
European Regulatory Roundup: EMA Explains How Patients Can Get Involved in Regulation (21 May 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 Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen.

Categories: Drugs, News, US, CDER Tags: PCAC, Pharmacy Compounding Advisory Committee, Pharmaceutical Compounding, Compounding
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
Regulatory Recon: FDA Poised for Funding Boost in 'Cures' Bill (21 May 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: House Releases New Draft of 'Cures' Bill (20 May 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: India Chided for Oversight of Fixed-Dose Combinations (19 May 2015)

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

Categories: Regulatory intelligence, News Tags: Asia Regulatory Roundup, Regulatory Roundup
EU Parliament Calls for Measures to Combat Antimicrobial Resistance

The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections.

Categories: Drugs, Government affairs, Research and development, Reimbursement, News, Europe, EMA, EC Tags: Antimicrobial resistance, AMR, European Parliament
To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species.

Categories: Drugs, Distribution, Postmarket surveillance, News, US, CDER Tags: AMR, Antimicrobial Resistance, NARMS, Regulation, Proposed Regulation, Antimicrobial Animal Drug Sales and Distribution Reporting
Regulatory Recon: Regulation of Stem Cells Challenges FDA (19 May 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
Company Challenges UK Clinical Trial Transparency Rules

An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports.

Categories: Clinical, News, Europe Tags: HRA, Health Research Authority, Clinical Trial Transparency, Clinical Data Transparency
FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.

Categories: Medical Devices, Clinical, News, US, CDRH Tags: Adaptive Design, Guidance, Draft Guidance
FDA Recommends Use of LOINC Data Standard

The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, CBER, CDER Tags: LOINC, Data, Data Standard, Logical Observation Identifiers Names and Codes
FDA Kicks Off MDUFA Reauthorization Process

The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities.

Categories: Medical Devices, News, US, CDRH Tags: MDUFA, Medical Device User Fee Act, MDUFA IV
Regulatory Recon: Drug Firms Challenge UK Trials Transparency Effort (18 May 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
RegBits: All the Regulatory News You Might Have Missed This Week

It's been a busy week in the world of regulatory affairs, and there's a lot of news we hoped to cover but never got around to. Read on to check our brief synopses of the stories we missed.

Categories: News, FDA Tags: RegBits
UK Review: New Models Needed to Fight Antimicrobial Resistance

A review of antimicrobial resistance (AMR), commissioned by the UK and led by internationally renowned economist Jim O'Neill, is calling for billions of dollars in new funding intended to incentivize drug development and head off the threat of drug-resistant disease.

Categories: Drugs, Research and development, Reimbursement, Regulatory strategy, News, Europe Tags: Antimicrobial resistance, AMR, drug discovery, Jim O'Neill
Regulatory Recon: 21st Century Cures Bill Clears House Subcommittee (15 May 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: HTA Bodies Encouraged to Cooperate (14 May 2015)

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

Categories: Regulatory intelligence, News Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
« 1 2 3 4 5  ... »