Search Results for Michael Mezher

Showing 1 – 25  of 519

FDA Issues Draft Guidance on NGS Sequencing for Infectious Disease Diagnostics By Michael Mezher - Published 12 May 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases.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

Tags: NGS, Next generation sequencing, Draft Guidance

Regulatory Recon: Experts Decry Tying Medical Research Funds to FDA Changes; BMS' Immuno-Oncology Combination Gets EU Approval (12 May 2016) By Michael Mezher - Published 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: 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 to Slow Reviews for Orphan Designation; Public Weighs in on Faster FDA Reviews (11 May 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA By Michael Mezher - Published 11 May 2016

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: News, US, FDA, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: Real world evidence, Sentinel, Robert Califf, FDLI

Regulatory Recon: Drugmakers Push to Stop Government Price Controls; Study Finds More Generic Substitution Could Save Billions (10 May 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

New Bill Would Speed FDA Review of OTC Contraceptives By Michael Mezher - Published 10 May 2016

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: News, US, FDA, Over the counter drugs, Prescription drugs, Submission and registration

Tags: Contraceptive mandate, Affordable Care Act, Rep. Mia Love (R-UT), Guttmacher Institute

FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices By Michael Mezher - Published 09 May 2016

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.

Categories: News, US, FDA, Manufacturing, Medical Devices, Regulatory strategy

Tags: 3D printing, additive manufacturing

Regulatory Recon: ICER Says Multiple Myeloma Drugs Are Too Costly, France Looks to Boost Biosimilar Uptake (9 May 2016) By Michael Mezher - Published 09 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

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

Regulatory Recon: FDA Backs Out of Recall for Scope-Cleaning Machine; MHRA Issues 'Borderline' Device Guidance (6 May 2016) By Michael Mezher - Published 06 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

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

Califf: Strong Workforce Necessary for FDA to Drive Innovation By Michael Mezher - Published 05 May 2016

The US Food and Drug Administration (FDA) can be a driving force for industry innovation but the agency needs a strong and talented workforce, Robert Califf, the recently confirmed FDA commissioner, said at the Food and Drug Law Institute's Annual Conference in Washington, DC, on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Regulatory Recon: CRISPR Won't Help Sick Patients Soon; EU Device Regulation to Move Forward in June (4 May 2016) By Michael Mezher - Published 04 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

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

Drug Safety Reports Still Uninformative, FDA Officials Say By Michael Mezher - Published 04 May 2016

Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article.

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

Tags: Investigational new drug application, IND, expedited safety reports

Regulatory Recon: Cancer Drug Prices Continue to Rise Despite Competition, CFDA Releases 186 Device Standards (3 May 2016) By Michael Mezher - Published 03 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

FDA Calls for Head-to-Head Trials in Revised Draft Guidance on Hepatitis C Drugs By Michael Mezher - Published 03 May 2016

The US Food and Drug Administration (FDA) on Tuesday released a revised version of its draft guidance on direct-acting antiviral (DAA) Hepatitis C virus (HCV) drugs, which calls on sponsors to conduct head-to-head Phase III studies for drugs in development.

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

EMA Finalizes Process Validation Guidance By Michael Mezher - Published 02 May 2016

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Manufacturing, Regulatory strategy

Tags: Process validation, process development, process evaluation, process verification

Regulatory Recon: FDA Approves Acadia's Nuplazid to Treat Parkinson's Hallucinations; France Gets G7 to Weigh in on Drug Pricing (2 May 2016) By Michael Mezher - Published 02 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues By Michael Mezher - Published 29 April 2016

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility.

Categories: News, India, Europe, EMA, FDA, WHO, Clinical, Generic drugs, Ethics, Preclinical, Submission and registration

Tags: Data integrity, Notice of Concern, Semler

Regulatory Recon: Abbott, AbbVie Announce Billion Dollar Acquisitions; New Bill Would Overhaul Opioid Approval Process (27 April 2016) By Michael Mezher - Published 28 April 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

Public Citizen Sues FDA Over Redacted Advisory Committee Info By Michael Mezher - Published 28 April 2016

The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members.

Categories: News, US, FDA, Government affairs

Tags: Public Citizen, Advisory Committee Members, Freedom of Information,

Democrats Renew Call for $1.9 Billion to Fight Zika By Michael Mezher - Published 27 April 2016

House and Senate Democrats are calling on their Republican counterparts to support a new standalone bill, supported by President Barack Obama, calling for $1.9 billion to fund efforts to combat the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Government affairs

Tags: Zika

Regulatory Recon: FDA Rejects Digital Pill Combo; Novartis Periodic Fever Drug Wins Three Breakthrough Designations (27 April 2016) By Michael Mezher - Published 27 April 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

Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development By Michael Mezher - Published 26 April 2016

Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: C-Path, biomarker validation, data sharing

Health Canada Finalizes IVD Labeling Guidance After 18 Years By Michael Mezher - Published 25 April 2016

The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998.

Categories: News, Canada, Health Canada, In vitro diagnostics, Labeling

Tags: Electronic Labeling, E-labeling, Blood glucose monitoring systems

Regulatory Recon: Walgreens Struggles to Distance Itself From Theranos, AstraZeneca to Sequence 2  Million Genomes (22 April 2016) By Michael Mezher - Published 22 April 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 Reviewers Still Skeptical on Sarepta DMD Drug, Slow Sales for PCSK9s Amid Pricing Debate (21 April 2016) By Michael Mezher - Published 21 April 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