Search Results for Michael Mezher

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FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

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

Tags: Expanded Access, Compassionate Use, Right-to-Try

Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 2017) By Michael Mezher - Published 20 September 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: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 2017) By Michael Mezher - Published 19 September 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

Biomarker Qualification: FDA Explains Process and Opportunities for Engagement By Michael Mezher - Published 19 September 2017

In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.

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

Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures

Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 2017) By Michael Mezher - Published 18 September 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

Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations By Michael Mezher - Published 18 September 2017

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors.

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

Tags: Quantitative Benefit-Risk Assessment, ICH M4E(R2)

EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes By Michael Mezher - Published 18 September 2017

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.

Categories: News, Europe, EMA, Biologics and biotechnology, Blood

Tags: Factor VIII, Inhibitor, Hemophilia A

FDA Finalizes HPV Diagnostic Study Guidance By Michael Mezher - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer.

Categories: News, US, FDA, In vitro diagnostics

Tags: HPV, Human Papillomavirus, Cervical Cancer

FDA Steps in to Regulate Microneedling Devices By Michael Mezher - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation.

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

Tags: Microneedling, Micro-needling, Draft Guidance

Regulatory Recon: AZ Sells Remaining Anesthetic Rights to Aspen for $766M; FDA Panel Unanimously Backs GSK Shingles Vaccine (14 September 2017) By Michael Mezher - Published 14 September 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 Plans to Finalize 510(k) Change Guidances Ahead of November Deadline By Michael Mezher - Published 13 September 2017

An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act.

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

Tags: 510(k) changes, 510(k) modification, Software

Regulatory Recon: Amicus Abandons Wound Treatment After Phase III Miss; Mylan Says Allergan Misusing Tribal Sovereignty (13 September 2017) By Michael Mezher - Published 13 September 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

Congress Takes First Look at User Fee Program for OTC Drugs By Michael Mezher - Published 13 September 2017

The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products.

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

Tags: OTC Monograph, OMOR, Over-the-Counter Monograph, User Fees

Regulatory Recon: Alexion Cutting 600 Jobs in Boston HQ Move; Teva Sells Paragard Contraceptive Business for $1.1B (12 September 2017) By Michael Mezher - Published 12 September 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

MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

Regulatory Recon: Teva Hires Lundbeck's Schultz as CEO; Updates from ESMO (11 September 2017) By Michael Mezher - Published 11 September 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: Sanofi, Regeneron Get Breakthrough Status for PD-1 Skin Cancer Candidate; New Mexico Sues 8 Opioid Makers and Distributors (8 September 2017) By Michael Mezher - Published 08 September 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

DHS Warns of 8 Cybersecurity Vulnerabilities in Smiths Medical Wireless Infusion Pumps By Michael Mezher - Published 08 September 2017

The Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (DHS ICS-CERT) on Thursday issued an advisory detailing eight cybersecurity vulnerabilities found in Smiths Medical's Medfusion 4000 wireless infusion pumps.

Categories: News, US, Medical Devices

Tags: Cybersecurity, Medfusion, Infusion Pump

Galena Biopharma Settles Opioid Kickback Allegations By Michael Mezher - Published 08 September 2017

Galena Biopharma has agreed to pay more than $7 million to settle allegations made in a whistleblower suit that the company gave kickbacks to doctors to boost prescriptions for the company's sublingual fentanyl drug Abstral.

Categories: News, US, DOJ, FDA, Advertising and Promotion, Drugs

Tags: Abstral, Galena

FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components By Michael Mezher - Published 07 September 2017

The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan.

Categories: News, US, FDA, Combination products, Drugs

Tags: Meridian Medical Technologies, Pfizer, Mylan, EpiPen, Warning Letter

Regulatory Recon: Eli Lilly to Lay Off 3,500 in Global R&D Cuts; FDA Puts Holds on BMS, Celgene Cancer Trials (7 September 2017) By Michael Mezher - Published 07 September 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

ICH Advances Q&A on Drug and Biologic Starting Materials By Michael Mezher - Published 07 September 2017

The International Council for Harmonisation (ICH) on Wednesday advanced a questions and answers guideline aimed at clarifying expectations for selecting and justifying starting materials for drug and biologic manufacturing.

Categories: News, ICH, Biologics and biotechnology, Drugs, Manufacturing

Novo Nordisk Pays $58M to Settle REMS Allegations By Michael Mezher - Published 06 September 2017

Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).

Categories: News, US, DOJ, FDA, Advertising and Promotion, Communication, Drugs

Tags: Novo Nordisk, Victoza, REMS

Regulatory Recon: Merck Buys German Immuno-Oncology Specialist Rigontec; NICE Again Rejects Takeda's Ninlaro for Multiple Myeloma (6 September 2017) By Michael Mezher - Published 06 September 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: FDA Halts Cellectis' Off-the-Shelf CAR-T Trial After Patient Death; Novartis Names New CEO (5 September 2017) By Michael Mezher - Published 05 September 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