Search Results for Michael Mezher

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EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda By Michael Mezher - Published 21 July 2017

The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.

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

Tags: CHMP

Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Current Offices (21 July 2017) By Michael Mezher - Published 21 July 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

EMA Recommends Suspending Certain Gadolinium Contrast Agents By Michael Mezher - Published 21 July 2017

The European Medicines Agency (EMA) on Friday said it plans to suspend the marketing authorization for three gadolinium contrast agents and restrict the use of others after a review by the agency's Pharmacovigilance Risk Assessment Committee (PRAC) confirmed evidence of gadolinium accumulation in patients' brains months after being injected.

Categories: News, Europe, EMA, Drugs

Tags: Gadolinium

FDA Clears First MRI Meant for Use in NICUs By Michael Mezher - Published 20 July 2017

The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs).

Categories: News, FDA, Medical Devices

Tags: MRI, Magnetic Resonance Imaging, Embrace Neonatal MRI, NICU

CDRH Clarifies Process for Consensus Standard Recognition Requests By Michael Mezher - Published 20 July 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices

Tags: Consensus Standards, 21st Century Cures Act

Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero; Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017) By Michael Mezher - Published 20 July 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 Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023.

Categories: News, US, FDA, Distribution, Drugs, Packaging

Tags: DSCSA, Supply Chain

FDA Warns Phototherapy Device Maker for Quality System Issues By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March.

Categories: News, US, FDA, Medical Devices

Tags: Warning Letter, National Biological Corporation

Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations; FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017) By Michael Mezher - Published 19 July 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 Approves Puma's Breast Cancer Drug Nerlynx; US Court Upholds Takeda Patent on Velcade (18 July 2017) By Michael Mezher - Published 18 July 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

Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 By Michael Mezher - Published 18 July 2017

By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, MAPP

Senate Appropriations Bill Maintains FDA Funding for 2018 By Michael Mezher - Published 18 July 2017

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Government affairs

Tags: Appropriations, FY2018, User Fees, Budget

Update: Gottlieb Lays Out Plans to Bolster FDA's Staff By Michael Mezher - Published 17 July 2017

Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs.

Categories: News, US, FDA

Tags: Recruitment, Hiring, Vacancies, User Fees

EMA Updates Guidance on Three Post-Authorisation Activities By Michael Mezher - Published 14 July 2017

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

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

Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation

Regulatory Recon: J&J Uses Priority Review Voucher to Speed Psoriasis Approval; DoJ Charges 412 in Healthcare, Opioid Schemes (14 July 2017) By Michael Mezher - Published 14 July 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

Report Calls on FDA to Adopt New Standard for Reviewing Opioids By Michael Mezher - Published 14 July 2017

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: News, US, FDA, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Opioids, Opioid Epidemic

FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

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

Tags: Avastin, Herceptin, Biosimilars, ADP 215, MYL-1401O

Regulatory Recon: Amgen's Blincyto Wins Full FDA Approval; NICE Backs Three Drugs for Plaque Psoriasis in Children (13 July 2017) By Michael Mezher - Published 13 July 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: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA Officials: Master Protocols Needed for Precision Medicine By Michael Mezher - Published 07 July 2017

In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple drugs or multiple diseases (or both) simultaneously are needed to efficiently generate evidence for precision medicines.

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

Tags: Master Protocols

Regulatory Recon: FDA Halts Three Keytruda Studies After Patient Deaths; Euro Biotech Firms Raised $2.3B in First Half of 2017 (6 July 2017) By Michael Mezher - Published 06 July 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

OPDP Study Raises Questions About the Balance of Information in Mobile Ads By Michael Mezher - Published 05 July 2017

A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: OPDP, Office of Prescription Drug Promotion, Mobile Ads

Regulatory Recon: NICE Expands Access to Strensiq; Stada Execs Step Down as Bain, Cinven Prepare New Bid (5 July 2017) By Michael Mezher - Published 05 July 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

Is FDA Too Slow? Researchers Debunk Claims By Michael Mezher - Published 03 July 2017

Despite being consistently ranked among the world's fastest regulators, the US Food and Drug Administration (FDA) is often criticized for being slow and bureaucratic.

Categories: News, US, FDA, Clinical, Drugs, Submission and registration

Regulatory Recon: Canada Supreme Court Hands Patent Victory to Pharma; GSK Signs $43m AI Drug Discovery Deal (3 July 2017) By Michael Mezher - Published 03 July 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