Search Results for Michael Mezher

Showing 1 – 25  of 604

FDA Declares ‘General Wellness’ Devices Exempt From Regulations By Michael Mezher - Published 28 July 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA

Democrats Tell FDA, CMS to Hand Over Theranos Data By Michael Mezher - Published 28 July 2016

A group of high-ranking Democrats sent letters to the heads of the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) this week asking them to turn over data from their investigations of blood testing startup Theranos.

Categories: News, US, FDA, Government affairs, In vitro diagnostics

Tags: Theranos

Regulatory Recon: Sanofi's Adlyxin Approved for Type 2 Diabetes; PhRMA, BIO Release Off-Label Communications Principles (28 July 2016) By Michael Mezher - Published 28 July 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: TauRX Alzheimer's Drug Fails in Phase III; GSK to Invest £275m in UK Manufacturing Sites (27 July 2016) By Michael Mezher - Published 27 July 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 Adds Four New Drugs to PRIME Scheme By Michael Mezher - Published 27 July 2016

The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: PRIME scheme, PRIority MEdicines, Novartis, Merck, Adaptimmune, DNATrix, CTL019, Ebola Vaccine, NY-ESO-1c259T, DNX-2401

MHRA Drops Pharmacovigilance Compliance Reporting Requirements By Michael Mezher - Published 26 July 2016

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) says it no longer wants drugmakers to submit regular drug safety surveillance compliance reports, unless they are specifically requested by the agency.

Categories: News, Europe, MHRA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, GPvP, GVP

FDA to Reevaluate Gay Blood Donor Guidance By Michael Mezher - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday called for public input on its December 2015 guidance that ended the agency's indefinite ban on gay men donating blood in favor of a 12-month deferral since the donor last had sex with another man.

Categories: News, US, FDA, Blood

Regulatory Recon: Baxter, Lilly Beat Sales Estimates; Gilead Lowers Guidance Amid Lower HCV Sales (26 July 2016) By Michael Mezher - Published 26 July 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 Panel Split Over Alere Diabetes Diagnostic; EMA Recommends Suspending Drugs Over Data Integrity Issues at Semler (25 July 2016) By Michael Mezher - Published 25 July 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 Sends Untitled Letter to Danish Drugmaker Over GMP Issues By Michael Mezher - Published 25 July 2016

The US Food and Drug Administration (FDA) has issued an untitled letter to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility.

Categories: News, Europe, US, CBER, Biologics and biotechnology, Manufacturing, Quality

Tags: ALK-Abelló, Untitled Letter, Pharmalgen

Regulatory Recon: Theranos Brings in New Regulatory, Compliance Execs; Valeant Gets CRL for Glaucoma Drug Over GMP Issues at Manufacturer (22 July 2016) By Michael Mezher - Published 22 July 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 to Revise Phase I Trial Guidance, Draft Expected in Late 2016 By Michael Mezher - Published 22 July 2016

The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Preclinical

Tags: First-in-Human, Phase I, Clinical Trials

Regulatory Recon: Novartis Gets Complete Response Letter for Neulasta Biosimilar; UK's First Minister of Life Sciences Moves On, Future of Office in Question (19 July 2016) By Michael Mezher - Published 19 July 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: Juno to Resume Cancer Immunotherapy Trial; FDA Expands Label for Pfizer Pneumonia Vaccine (13 July 2016) By Michael Mezher - Published 13 July 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 Approves Shire's Potential Blockbuster Xiidra for Dry Eye Disease; Sage Postpartum Depression Drug Succeeds in Phase II Trial (12 July 2016) By Michael Mezher - Published 12 July 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

Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria By Michael Mezher - Published 12 July 2016

A team of researchers say that no currently available patient-reported outcomes for heart failure meet the US Food and Drug Administration's (FDA) criteria for supporting product approval.

Categories: News, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Patient-reported outcomes, PRO, Heart failure

Regulatory Recon: Pharma Spends on Lawmakers Against Medicare Part B Overhaul; GSK, AZ to Head Brexit Task Force (11 July 2016) By Michael Mezher - Published 11 July 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: ROCKET AF Investigators Say Analysis Supports Original Results; NICE Backs Pfizer's Bosulif in First Cancer Drug Fund Reappraisal (7 July 2016) By Michael Mezher - Published 07 July 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 Approves Abbott Absorbable Heart Stent; Sanofi Teams Up With US Army to Develop Zika Vaccine (6 July 2016) By Michael Mezher - Published 06 July 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

Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results By Michael Mezher - Published 06 July 2016

A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards.

Categories: News, US, FDA, Government affairs, In vitro diagnostics

Tags: Theranos, CMS, Test Results, Edison

Regulatory Recon: Big Pharma Wary of Teva Joining Trade Group; BMS Buys Cancer, Rare Disease Firm Cormorant (5 July 2016) By Michael Mezher - Published 05 July 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 Zimmer Over Quality System Issues at Montreal Plant By Michael Mezher - Published 05 July 2016

The US Food and Drug Administration (FDA) has issued medical device maker Zimmer Biomet a warning letter over nine quality system issues uncovered at its facility in Montreal.

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

Tags: Quality System, Zimmer Biomet, Orthosoft, Warning Letter

Regulatory Recon: FDA Approves Humira for 10th Indication; Unproven Stem Cell Centers Spreading Across the US (1 July 2016) By Michael Mezher - Published 01 July 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 Two Chinese Drugmakers for Data Integrity Violations By Michael Mezher - Published 30 June 2016

The US Food and Drug Administration (FDA) has issued warning letters to two Chinese drugmakers over manufacturing and data integrity issues, including backdated tests and falsified records.

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

Tags: Data integrity, Warning letter

Regulatory Recon: FDA Seeks Safety, Efficacy Data for OTC Hand Sanitizers; India Revises Draft Biosimilar Guidelines (30 June 2016) By Michael Mezher - Published 30 June 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