Search Results for Zachary Brennan

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Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says By Zachary Brennan - Published 16 May 2016

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: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Crisis management, Drugs, Government affairs

Tags: compassionate use, Reagan-Udall Foundation, expanded access, right to try

EHR Data in Clinical Trials: New FDA Draft Guidance By Zachary Brennan - Published 16 May 2016

The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health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: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Medical Devices, Research and development

Tags: EHR data, EHR guidance, clinical trials and electronic health records, health IT, ONC

Regulatory Recon: US Supreme Court Sends Obamacare Contraceptive Challenge to Lower Court; Pfizer Acquires Anacor for $5.2B (16 May 2016) By Zachary Brennan - Published 16 May 2016

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

Categories: News, Asia, Europe, Oceania, US, CDSCO, EC, EMA, FDA, Health Canada, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Crisis management, Drugs, Government affairs, Labeling, Medical Devices, Postmarket surveillance, Quality

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives By Zachary Brennan - Published 16 May 2016

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: News, US, FDA, Drugs

Tags: Merck KGaA, Bayer, Beyaz, contraceptives, fax machine, drug patents

FDA Finalizes Guidance on Postmarket Device Surveillance By Zachary Brennan - Published 13 May 2016

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: News, US, CDRH, Clinical, Medical Devices, Postmarket surveillance

Tags: medical device postmarket studies, device surveillance, postmarket med dev studies, 522 order

European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs By Zachary Brennan - Published 13 May 2016

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: News, Europe, EC, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: medical device manufacturing standards, device manufacturing, ISO standards

Regulatory Recon: Judge Backs Obamacare Challenge; White House Launches Microbiome Initiative (13 May 2016) By Zachary Brennan - Published 13 May 2016

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

Categories: News, Africa, Asia, Europe, US, EC, EMA, FDA, Health Canada, WHO, Biologics and biotechnology, Combination products, Compliance, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Research and development

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA

FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases By Zachary Brennan - Published 12 May 2016

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: News, US, FDA, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Fluoroquinolone, FDA safety communications

70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names By Zachary Brennan - Published 12 May 2016

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: News, US, CBER, Biologics and biotechnology, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilar names, Zarxio, meaningful suffixes for biosimilars, FDA guidance

US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries By Zachary Brennan - Published 12 May 2016

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: News, Asia, Europe, Middle East, US, FDA, Biologics and biotechnology, Crisis management, Government affairs

Tags: generic cancer drugs, Heritage Pharmaceuticals

European Regulators Drawn Into Debate on Drug Pricing By Zachary Brennan - Published 12 May 2016

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: News, Europe, US, EC, EMA, MHRA, NICE, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: EU drug prices, pharmaceutical drug pricing, drug price policies, EMA and drug pricing

PBMs, Payers Exclude Coverage for Growing Number of Priciest Drugs By Zachary Brennan - Published 12 May 2016

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: News, US, FDA, FTC, Biologics and biotechnology, Clinical, Drugs, Reimbursement

Tags: CVS, Express Scripts, PBM, expensive drug costs

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

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: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

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: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

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: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

FDA Considers New User Fee Program for OTC Drugs By Zachary Brennan - Published 10 May 2016

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: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Government affairs

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 By Zachary Brennan - Published 10 May 2016

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: News, Asia, Europe, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Research and development

Tags: NIH, exclusive start-up licenses, FDA inventions, FDA labs

Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals By Zachary Brennan - Published 09 May 2016

The 800 pages of internal emails, correspondence and drug pricing statistics released by the Senate Special Committee on Aging over the weekend offers an inside look at how the multi-billion dollar Valeant Pharmaceuticals with 22,000+ employees jacked up the prices of a number of drugs, by as much as 6,000%, and then lamented the subsequent media and investor questions.

Categories: News, Canada, US, Compliance, Crisis management

Tags: Valeant Pharmaceuticals, drug pricing, pharmaceutical prices

FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest By Zachary Brennan - Published 09 May 2016

The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest.

Categories: News, US, CDRH, Clinical, Crisis management, Medical Devices, Regulatory intelligence

Tags: medical device panel, St. Jude Medical, Amplatzer, PFO Occluder, FDA advisory committee, conflict of interest

ICH Looks to Global Expansion By Zachary Brennan - Published 06 May 2016

The newly renamed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is looking to bring more pharmaceutical and medical device regulators into its ranks as members and observers.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, ICH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, pharmaceutical regulators

GOP Senators Raise Concerns With FDA’s Draft Guidance Policies By Zachary Brennan - Published 06 May 2016

Four Republican senators sent a letter on Friday to US Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency’s inability to revise, finalize or withdraw draft guidance documents in a timely manner.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Regulatory strategy

Tags: draft guidance, FDA policy on guidance documents

Researchers Urge Caution on Expanding Priority Review Voucher Programs By Zachary Brennan - Published 06 May 2016

As Congress looks to further expand current priority review voucher (PRV) programs (and even create entirely new ones), researchers are now cautioning that the worth of the vouchers could decline significantly and diminish incentives to develop drugs for neglected diseases.

Categories: News, US, FDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: priority review vouchers, PRV, tropical disease treatments, pharmaceutical incentives

Regulatory Recon: E-Cigarettes Come Under FDA Purview; Panel Calls for Mandatory Opioid Training for Doctors (5 May 2016) By Zachary Brennan - Published 05 May 2016

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

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, US, CDSCO, EC, EMA, FDA, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Quality

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulating Precision Medicine: Capacity vs. Overreach By Zachary Brennan - Published 05 May 2016

As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine.

Categories: News, Oceania, US, FDA, Biologics and biotechnology, Combination products, Drugs, Ethics, Government affairs

Tags: precision medicine, regulating DTC genomic tests, 23andMe

Three FDA Final Rules Slated for Release in May By Zachary Brennan - Published 04 May 2016

Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Medical Devices

Tags: device trial data, combo product safety, pharmaceutical manufacturing facilities