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.

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
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
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
One Year Into 'openFDA'

In June 2014, the US Food and Drug Administration (FDA) launched a technology-driven "openFDA" initiative to make it easier to access and interpret the agency's publicly available data.

Categories: Drugs, Medical Devices, Government affairs, Labeling, Postmarket surveillance, News, US, FDA Tags: openFDA, Taha Kass-Hout
Regulatory Recon: Ruling in Biosimilar Case Could Impact Future Launches (22 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
MHRA Wants Input on Single-Use Device Re-Manufacture Guidance

The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices.

Categories: Medical Devices, Government affairs, Labeling, Manufacturing, Packaging, Quality, News, Europe, EC, MHRA Tags: Single-use device, Reprocessing, Re-manufacturing
Regulatory Recon: Buggy Batch of Saline Gets Recalled (21 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
Asia Regulatory Roundup: Shanghai to Host New Drug Evaluation Center to Speed CFDA Approvals (21 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, News, China, India, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making?

Categories: Drugs, News, US, FDA, Advertising and Promotion, Communication Tags: Advertising and promotion, efficacy, Office of Prescription Drug Promotion
Regulatory Recon: Is NASA Looking at the Drug Distribution Game? (20 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
FDA: What's Slowing Progress in Some Disease Areas?

In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology.

Categories: Biologics and biotechnology, Drugs, Clinical, Research and development, Regulatory strategy, News, US, FDA Tags: Precision Medicine, Biomarkers, Surrogate Endpoints, HCV, Alzheimer's, Robert Califf
Regulatory Recon: FDA: Approval Process Isn't Holding Targeted Medicine Back (17 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, FDA, EMA, EC, MHRA, NICE, Health Canada, TGA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA and Google Talk 'Adverse Event Trending'

Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports.

Categories: Drugs, Postmarket surveillance, News, US, FDA Tags: Google, pharmacovigilance, adverse events, side effects
EMA Launches Parallel Distribution Database

To boost transparency for re-exported drugs, the European Medicines Agency (EMA) has created a new publicly available online register for parallel distribution notices.

Categories: Biologics and biotechnology, Drugs, Distribution, Labeling, News, Europe, EMA Tags: Distribution, Parallel distribution, re-export
European Regulatory Roundup: EMA Launches Probe Into HPV Vaccine Safety (16 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: PDUFA VI, Senate Committee OKs FDA Funding Bill (16 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
PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting

The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA).

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA, Communication Tags: PDUFA, PDUFA VI, PDUFA reauthorization, PhRMA
Regulatory Recon: Senate Democrats Tell FDA to Finish Lifting Gay Blood Ban (15 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
FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications.

Categories: Medical Devices, Submission and registration, News, US, FDA Tags: Magnetic resonance diagnostic device, Magnetic resonance imaging, MRDD, MRI, 510(k)
Asia Regulatory Roundup: China to Begin Surprise Inspections, India to Monitor Medical Device Safety (14 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, News, China, India, Oceania, CFDA, CDSCO, TGA, Medsafe Tags: Asia Regulatory Roundup, Regulatory Roundup
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