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.

FDA Unveils User Fee Rates for FY2016

The US Food and Drug Administration (FDA) has just released the rates for the various user fees charged to industry for fiscal year 2016.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Veterinary products, Government affairs, Submission and registration, News, US, FDA Tags: PDUFA, MDUFA, GDUFA, ADUFA, AGDUFA, User fees
Asia Regulatory Roundup: Chinese Distillers Suspected of Lacing Alcohol with Viagra (4 August 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Japan, China, India, Oceania, MHLW, PMDA, CFDA, MFDS, CDSCO, TGA, APEC Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: FDA Approves First-Ever 3D Printed Drug (4 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: 2016 User Fees are Here! Plus, '100% Effective' Ebola Vaccine and Cybersecurity Woes (3 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 Isn't Waiting Around for 'Cures' to Speed Access to Devices

While the Congress is busy working on the 21st Century Cures Act, which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands.

Categories: Medical Devices, Submission and registration, News, US, FDA Tags: Humanitarian device exemption, Premarket approval
Eight Years on, FDA Celebrates its Scientific Advancement

Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007.

Categories: Biologics and biotechnology, Drugs, Research and development, News, US, FDA Tags: Regulatory science, Science Board,
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
Japan Edges out FDA for Fastest Approvals

In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs).

Categories: Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration, News, US, Europe, Japan, FDA, EMA, MHLW, PMDA Tags: New drug approvals, New active substance, NAS, Centre for Innovation in Regulatory Science, CIRS, ICH, Orphan drugs, Expedited review, Priority Review
FDA: Brand Name Confusion Led to Dozens of Medication Errors

The US Food and Drug Administration (FDA) has issued a safety alert for two drugs, Brintellix and Brilinta, after receiving 50 reports of confusion between them caused by similarities in the drugs' names.

Categories: Drugs, Labeling, Postmarket surveillance, News, US, FDA Tags: Brand names, Proprietary names, Drug naming, Medication errors, Brintellix, Brilinta
Regulatory Recon: GSK Accused of Bribery in Romania as Gov't Probes 11 Cancer Drugmakers (31 July 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
EMA: Revised Rules for GCP and Veterinary Type IA Fees Take Effect

The European Medicines Agency (EMA) is reminding companies that beginning 1 August 2015, several changes to its implementing rules on fees payable to the agency will enter into force.

Categories: Drugs, Veterinary products, Clinical, Regulatory strategy, News, Europe, EMA Tags: Fees, Good clinical practice, GCP
European Regulatory Roundup: EMA Revises Guidelines for Fast-Track Approval Pathways (30 July 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA, NICE, WHO Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
Regulatory Recon: FDA Preps for Turbulence as User Fees, 'Cures' Act and Elections Approach (30 July 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: Quality Metrics, Robotic Surgery Regulation and Who's to Blame in Anthrax Scandal (29 July 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
EMA Hopes to Boost Drug Safety in Scientific Advice Pilot

In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS).

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory strategy, News, Europe, EMA Tags: Post-authorization safety studies, PASS, SAWP, PRAC
FDA Releases Long-Awaited Quality Metrics Guidance

Monday, the US Food and Drug Administration (FDA) released a draft guidance detailing how it plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate potential drug shortages.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory strategy Tags:
Regulatory Recon: Risk of Brain Deposits Prompts FDA to Calls for Limiting Gadolinium-Based Contrast Use (28 July 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
Asia Regulatory Roundup: CFDA Orders Audit of Clinical Trial Data to Root out Forged Submissions (28 July 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Regulatory strategy, News, Oceania, CFDA, CDSCO Tags: Asia Regulatory Roundup, Regulatory Roundup
EMA to Review InductOs After US Manufacturer Cited for Contamination Issues

The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components.

Categories: Drugs, Compliance, Manufacturing, Postmarket surveillance, Quality, News, US, Europe, EMA, EC Tags: InductOs, Medtronic, Article 20 procedure, Good manufacturing practice, GMP, Integra LifeSciences
Regulatory Recon: Catching Up on FDA's Approval Blitz and the Latest Pricing Chatter (27 July 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
Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization.

Categories: Biologics and biotechnology, Regulatory strategy, Europe, Asia, Latin America and Caribbean, Africa, EMA, WHO Tags: Mosquirix, GSK, Article 58, malaria
Regulatory Recon: EMA Recommends First Malaria Vaccine for Use Outside the EU (24 July 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
EMA Announces Sweeping Overhaul of Pediatric Class Waivers

In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized.

Categories: Biologics and biotechnology, Drugs, Orphan products, Clinical, Compliance, Ethics, Regulatory strategy, News, Europe, EMA Tags: Paediatric Committee, Paediatric Investigation Plan, PIP, Class Waiver
European Regulatory Roundup: UK Regulator Gets Positive Score in Government Review (23 July 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Caution, Hope and Excitement in Alzheimer's Fight (23 July 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
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