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.

How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives

The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent.

Categories: Drugs, News, US, FDA Tags: Merck KGaA, Bayer, Beyaz, contraceptives, fax machine, drug patents
EHR Data in Clinical Trials: New FDA Draft Guidance

The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Government affairs, Research and development, News, US, FDA Tags: EHR data, EHR guidance, clinical trials and electronic health records, health IT, ONC
Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says

The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better.

Categories: Biologics and biotechnology, Combination products, Drugs, Clinical, Crisis management, Government affairs, News, US, FDA Tags: compassionate use, Reagan-Udall Foundation, expanded access, right to try
Regulatory Recon: US Supreme Court Sends Obamacare Contraceptive Challenge to Lower Court; Pfizer Acquires Anacor for $5.2B (16 May 2016)

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

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Crisis management, Government affairs, Labeling, Postmarket surveillance, Quality, News, US, Europe, Asia, Oceania, FDA, EMA, EC, Health Canada, CDSCO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Regulatory Recon: Judge Backs Obamacare Challenge; White House Launches Microbiome Initiative (13 May 2016)

Happy Friday the 13th! And welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. 

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Crisis management, Compliance, Government affairs, Manufacturing, Research and development, Quality, News, US, Europe, Asia, Africa, FDA, EMA, EC, Health Canada, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA
FDA Finalizes Guidance on Postmarket Device Surveillance

The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices.

Categories: Medical Devices, Clinical, Postmarket surveillance, News, US, CDRH Tags: medical device postmarket studies, device surveillance, postmarket med dev studies, 522 order
European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law.

Categories: In vitro diagnostics, Medical Devices, Manufacturing, Regulatory strategy, Regulatory intelligence, Submission and registration, News, Europe, EC, ISO Tags: medical device manufacturing standards, device manufacturing, ISO standards
PBMs, Payers Exclude Coverage for Growing Number of Priciest Drugs

Two of the largest pharmacy benefit managers (PBMs) in the US are excluding a growing number of costly drugs from their formularies (ie. the drugs are not eligible for reimbursement), as the fight over drug costs is beginning to take a turn toward clinical and cost-effectiveness.

Categories: Biologics and biotechnology, Drugs, Clinical, Reimbursement, News, US, FDA, FTC Tags: CVS, Express Scripts, PBM, expensive drug costs
70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names

The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars.

Categories: Biologics and biotechnology, Government affairs, Labeling, Regulatory strategy, Regulatory intelligence, News, US, CBER Tags: biosimilar names, Zarxio, meaningful suffixes for biosimilars, FDA guidance
FDA Issues Draft Guidance on NGS Sequencing for Infectious Disease Diagnostics

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases.

Categories: In vitro diagnostics, Clinical, News, US, FDA Tags: NGS, Next generation sequencing, Draft Guidance
US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries

New Jersey-based generic drugmaker Heritage Pharmaceuticals last week announced that counterfeit drugs labeled the same as its 100mg chemotherapy BiCNU (carmustine for injection) have been sold and distributed in India, Ireland and Israel.

Categories: Biologics and biotechnology, Crisis management, Government affairs, News, US, Europe, Asia, Middle East, FDA Tags: generic cancer drugs, Heritage Pharmaceuticals
FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

The US Food and Drug Administration (FDA) on Thursday advised that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections (UTIs) who have other treatment options.

Categories: Drugs, Crisis management, Labeling, Postmarket surveillance, News, US, FDA Tags: Fluoroquinolone, FDA safety communications
European Regulators Drawn Into Debate on Drug Pricing

Although drug regulators aren’t supposed to be concerned with pricing when making decisions on products’ safety and efficacy, they’re increasingly being drawn into what two representatives of the European Medicines Agency (EMA) and the heads of two national regulators call an “acrimonious debate” over drug costs.

Categories: Biologics and biotechnology, Drugs, Crisis management, Government affairs, News, US, Europe, EMA, EC, MHRA, NICE Tags: EU drug prices, pharmaceutical drug pricing, drug price policies, EMA and drug pricing
Regulatory Recon: Experts Decry Tying Medical Research Funds to FDA Changes; BMS' Immuno-Oncology Combination Gets EU Approval (12 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan 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
European Regulatory Roundup: MHRA, UK Biopharma Industry Warn Against Brexit (12 May 2016)

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

Categories: Crisis management, Government affairs, Quality, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, EMA, MHRA, Brexit, UK biopharmaceuticals
Industry Calls for More Guidance From FDA on New Clinical Trials Technology

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: Medical Devices, Clinical, Government affairs, Research and development, News, US, FDA Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology
Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA

The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week.

Categories: Drugs, Clinical, Regulatory strategy, Submission and registration, News, US, FDA Tags: Real world evidence, Sentinel, Robert Califf, FDLI
Former FDA and NIH Heads Call for Regulatory Harmonization

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, Africa, FDA, EMA, MHRA, Health Canada, CDSCO, ICH, IMDRF, GHTF, WHO Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi
EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Crisis management, Labeling, Postmarket surveillance, News, Europe, EMA, MHRA Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis
Regulatory Recon: FDA to Slow Reviews for Orphan Designation; Public Weighs in on Faster FDA Reviews (11 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan 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
New Bill Would Speed FDA Review of OTC Contraceptives

A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women.

Categories: Prescription drugs, Over the counter drugs, Submission and registration, News, US, FDA Tags: Contraceptive mandate, Affordable Care Act, Rep. Mia Love (R-UT), Guttmacher Institute
FDA Considers New User Fee Program for OTC Drugs

The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Compliance, Government affairs, News, US, FDA Tags: OTC monograph, FDA user fee programs, decongestants, over the counter cough medicines
NIH’s Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes

It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.

Categories: Biologics and biotechnology, Combination products, Drugs, Clinical, Compliance, Government affairs, Research and development, News, US, Europe, Asia, FDA Tags: NIH, exclusive start-up licenses, FDA inventions, FDA labs
Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Regulatory strategy, News, Asia, CFDA, CDSCO Tags: Asia Regulatory Roundup, Sanofi, dengue vaccine, vaccine scandal in China
Regulatory Recon: Drugmakers Push to Stop Government Price Controls; Study Finds More Generic Substitution Could Save Billions (10 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan 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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