Search Results for Michael Mezher

Showing 1 – 25  of 675

ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning By Michael Mezher - Published 23 September 2016

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible.

Categories: News, FDA, ISO, Medical Devices

Tags: ISO 13485:2016

FDA Approves First Humira Biosimilar By Michael Mezher - Published 23 September 2016

The US Food and Drug Administration (FDA) on Friday announced it had approved Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's best-selling biologic Humira (adalimumab).

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

Tags: Humira, Amjevita, Biosimilar, adalimumab, adalimumab-atto

Regulatory Recon: States Allege Indivior Tried to Block Generic Competition for Suboxone; Novartis' Zykadia Successful in Lung Cancer Phase III (23 September 2016) By Michael Mezher - Published 23 September 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: 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: Allergan to Buy Tobira in $1.7b Deal; GSK Names Emma Walmsley as New CEO (20 September 2016) By Michael Mezher - Published 20 September 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: 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: Drugmakers Fought State Opioid Limits; FDA Approves Sarepta DMD Drug (19 September 2016) By Michael Mezher - Published 19 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's By Michael Mezher - Published 19 September 2016

Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research.

Categories: Biologics and biotechnology, Drugs

Tags: Alzheimer's Disease, Data Sharing

Regulatory Recon: EMA Recommends 11 Drugs for Approval, Including Cancer Drugs From Lilly, Pfizer and Takeda (16 September 2016) By Michael Mezher - Published 16 September 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: News, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: FDA Panel Narrowly Supports Removing Chantix Boxed Warning; FDA Approves New Heart Drug Yosprala (15 September 2016) By Michael Mezher - Published 15 September 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: 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: In Depth Look Inside Biotech Startup Moderna; Postmarketing Study Fails to Ease FDA Concerns on Pfizer's Chantix (13 September 2016) By Michael Mezher - Published 13 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

GAO Report: 315 Generics More Than Doubled in Price Since 2010 By Michael Mezher - Published 13 September 2016

A new report by the US Government Accountability Office (GAO) found that the price for generic drugs under Medicare Part D fell significantly since 2010 despite some "extraordinary" increases for 315 generics.

Categories: News, US, Generic drugs, Reimbursement

Study: Cancer Drug Websites More Likely to Offer Data on Benefits Than Risks By Michael Mezher - Published 12 September 2016

Researchers from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) and research firm RTI International say that websites for cancer-drugs are ten times more likely to include quantitative information about all the benefits of a drug versus all its risks.

Categories: News, Advertising and Promotion, Biologics and biotechnology, Drugs

Regulatory Recon: Sanofi and Verily Team up in $500m Diabetes JV; Horizon Buys Raptor for $800m (12 September 2016) By Michael Mezher - Published 12 September 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: 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: Review Finds Statin Benefits Understated; Pfizer CEO Knocks Clinton's Plan to Curb Drug Price Increases (9 September 2016) By Michael Mezher - Published 09 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

Regulatory Recon: FDA Warns Against Ovarian Cancer Test; Takeda Launches Global Phase III for Dengue Vaccine (8 September 2016) By Michael Mezher - Published 08 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Begins Consultation on Two ICH Guidelines By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA) has issued two new International Council for Harmonisation (ICH) guidelines for public consultation: one on multi-regional clinical trials (MRCTs) and one on microsampling in study animals.

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

Tags: Multi-regional clinical trials, Microsampling, ICH

Regulatory Recon: Tonix Walks Away From Fibromyalgia Drug in Phase III; NIH Looks to License Anti-CD19 CAR Technology to Sangamo (7 September 2016) By Michael Mezher - Published 07 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Warns Pan Over Data Integrity, Sanitation Issues By Michael Mezher - Published 07 September 2016

For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity, Pan Drugs, Warning Letter

FDA Extends UDI Compliance for Certain Class II Devices By Michael Mezher - Published 07 September 2016

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: UDI, Unique Device Identifier, Class II

Regulatory Recon: Allergan CEO Vows to Limit Drug Price Increases; Danaher to Buy Cepheid for $4B (6 September 2016) By Michael Mezher - Published 06 September 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays By Michael Mezher - Published 02 September 2016

The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product.

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: 510(k), X-ray

Regulatory Recon: Clinton Looks to Increase Fines for Drug Price Gouging (2 September 2016) By Michael Mezher - Published 02 September 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: 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: FDA, Industry Reach Agreement on GDUFA II; CFDA Proposes Priority Review Pathway for Devices (1 September 2016) By Michael Mezher - Published 01 September 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: 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: Theranos Withdraws Zika Test After FDA Inspection; Novartis Lays Off 120 From CAR-T Unit (31 August 2016) By Michael Mezher - Published 31 August 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans By Michael Mezher - Published 31 August 2016

A group of 20 Senate democrats on Tuesday sent a letter to Mylan CEO Heather Bresch, questioning her about her company's actions in response to criticism over price increases for its life-saving EpiPen, which rose in price more than 400% over the past decade.

Categories: News, US, FDA, Combination products

Tags: Mylan, EpiPen