Search Results for Michael Mezher

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Regulatory Recon: Trump Taps Lobbyist for FDA Role During Transition; Global Coalition Aims to Prevent Future Epidemics (19 January 2017) By Michael Mezher - Published 19 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Updated: FDA and EMA in 2016: A Look at the Numbers By Michael Mezher - Published 19 January 2017

The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: New active substances, New molecular entity, Approvals

Regulatory Recon: Drugmakers say New FDA Commissioner Should Have Medical Experience; Pharma Industry Reacts to UK PM May's Brexit Speech (18 January 2017) By Michael Mezher - Published 18 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

CBER Announces Planned Guidance for 2017 By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research on Wednesday announced the guidance documents it plans to publish in 2017.

Categories: News, US, CBER, Biologics and biotechnology, Blood

Tags: Guidance

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives; ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017) By Michael Mezher - Published 17 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Trump Promises 'Insurance for Everybody'; FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017) By Michael Mezher - Published 16 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging By Michael Mezher - Published 16 January 2017

The US Food and Drug Administration (FDA) last week finalized its guidance on repackaging drugs by pharmacies and registered outsourcing facilities and also issued a revised draft guidance detailing its policies on mixing, diluting and repackaging certain types of biological products outside of the scope of an approved biologics license application (BLA).

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices By Michael Mezher - Published 13 January 2017

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: News, Europe, US, EC, FDA, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Adverse Event Reports, AER, Safety

Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick; Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017) By Michael Mezher - Published 13 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Trump Meets with NIH Contenders; NICE Backs Novartis Kidney Cancer Drug (12 January 2017) By Michael Mezher - Published 12 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs By Michael Mezher - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: Investigational Device Exemption, Final Guidance

FDA Offers Draft Guidance on New Pre-Request for Designation Process By Michael Mezher - Published 12 January 2017

After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Pre-Request for Designation, Pre-RFD, Combination Products

FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices By Michael Mezher - Published 11 January 2017

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter

Regulatory Recon: Merck Gambles on Early sBLA for Keytruda Combo; FDA Accepts BLA Mylan & Biocon's Proposed Biosimilar Trastuzumab (11 January 2017) By Michael Mezher - Published 11 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs By Michael Mezher - Published 11 January 2017

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: National Cancer Institute, NCI, NCI Formulary, Oncology

Regulatory Recon: Highly-Valued Moderna Hits Safety Problems with Lead Drug; HHS Secretary Calls for Medicare to Negotiate Drug Prices (10 January 2017) By Michael Mezher - Published 10 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Issues Labeling Guidance for Aspirin, Acetaminophen By Michael Mezher - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products.

Categories: News, US, FDA, Over the counter drugs, Labeling, Packaging

Tags: Aspirin, Acetaminophen

GAO: FDA's White Oak Campus Poses Security Risk By Michael Mezher - Published 09 January 2017

According to a new report from the Government Accountability Office (GAO), parking and cramped offices at the US Food and Drug Administration's (FDA) White Oak campus in Maryland pose a security risk for the agency.

Categories: News, US, FDA, Government affairs

Tags: FDA White Oak Campus, GAO, Government Accountability Office

Regulatory Recon: Takeda Buys Ariad for $5.2 Billion; Merrimack to Sell Oncology Assets to Ipsen (9 January 2017) By Michael Mezher - Published 09 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Danish Regulator Suspends Parallel Importer's GMP Certificate By Michael Mezher - Published 06 January 2017

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

Categories: News, Europe, Compliance, Distribution, Drugs, Packaging

Tags: Danish Medicines Agency, Europharma DK

CBER Director Touts Center's FY2016 Performance By Michael Mezher - Published 06 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: CBER, PDUFA, MDUFA, BLA

Regulatory Recon: CDC Hid Numerous Mishaps With Deadly Germs; High Priced Drugs to Blame for Rise in Medicare Part D Spending (5 January 2017) By Michael Mezher - Published 05 January 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

European Commission Clears up Questions on Orphan Drug Regulation By Michael Mezher - Published 05 January 2017

Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Regulation, Orphan Drugs, Orphan Designation