Search Results for Michael Mezher

Showing 1 – 25  of 763

FDA Classifies Post-Concussion Test By Michael Mezher - Published 05 December 2016

Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.

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

Tags: ImPACT, Concussion, Post-Concusion, Class II, De Novo

Regulatory Recon: Senate to Begin Cures Debate Tonight; FDA Close to Finishing Combination Product Reporting Rule (5 December 2016) By Michael Mezher - Published 05 December 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

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 Finalizes Guidance on Labeling By Michael Mezher - Published 02 December 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Labeling

Tags: Clinical pharmacology

Regulatory Recon: J&J Hit With $1Bn Verdict in Hip Implant Trial; TPP Exit Forces Look at Global Biopharma IP Challenges (2 December 2016) By Michael Mezher - Published 02 December 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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: Bluebird Reports Promising Results From Small CAR-T Study;Top US Heart Docs Want Califf to Continue as FDA Commissioner (1 December 2016) By Michael Mezher - Published 01 December 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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

Top FDA Officials Defend Agency Stance on Stem Cell Therapies By Michael Mezher - Published 01 December 2016

Officials from the US Food and Drug Administration (FDA) are defending its proposed approach to regulating stem cell therapies in response to criticism that doing so would slow access to such treatments.

Categories: News, US, FDA, Human cell and tissue

Tags: Stem cells

Regulatory Recon: Pfizer Herceptin Biosimilar Succeeds in Key Study; Pharma Companies Argue Against New UK Regulator (30 November 2016) By Michael Mezher - Published 30 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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 Specialty Pharma Company Over Adverse Event Reporting By Michael Mezher - Published 30 November 2016

The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: STI Pharma LLC, Postmarketing Adverse Drug Experience, PADE

Final FDA Rule Reworks Import Data Submissions By Michael Mezher - Published 30 November 2016

The US Food and Drug Administration (FDA) on Tuesday issued a final rule requiring companies to submit data for FDA-regulated products via a new electronic system intended to serve as a "single access point" for imported products.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Human cell and tissue, Medical Devices

Tags: ACE, Automated Commercial Environment

EMA Highlights Central Nervous System Drug Development Challenges By Michael Mezher - Published 29 November 2016

The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia.

Categories: News, Europe, EMA, Clinical, Drugs, Preclinical, Submission and registration

Tags: Central nervous system disorders, CNS

Regulatory Recon: Trump Picks Tom Price as HHS Secretary; Apple Emails Hint at Plans for FDA-Regulated Devices (29 November 2016) By Michael Mezher - Published 29 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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: 'Cures' Act Set for Wednesday Vote; J&J Looks to Acquire Actelion (28 November 2016) By Michael Mezher - Published 28 November 2016

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 Sees Better Industry Compliance With Postmarket Requirements By Michael Mezher - Published 28 November 2016

A new report from the US Food and Drug Administration (FDA) reveals improvements made by industry in complying with postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for Fiscal Year (FY) 2015.

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

Tags: Postmarketing commitments, Postmarketing requirements

Regulatory Recon: Lilly Alzheimer's Drug Fails in Phase III; Juno CAR-T Study Halted After Additional Deaths (23 November 2016) By Michael Mezher - Published 23 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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 Revises Quality Metrics Guidance, Says Program Will Be Voluntary Until 2018 By Michael Mezher - Published 23 November 2016

The US Food and Drug Administration (FDA) on Wednesday released a revised version of its proposal to collect quality metrics data from drugmakers in response to protests from industry.

Categories: News, US, FDA, Drugs, Manufacturing, Quality

Tags: Quality Metrics, Revised draft guidance

Regulatory Recon: FDA OKs Allergan Glaucoma Stent, J&J's Darzalex for MM; Novo, Sanofi Face Off After Diabetes Approvals (22 November 2016) By Michael Mezher - Published 22 November 2016

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 Warns Wockhardt Subsidiary Over Aseptic Production Issues By Michael Mezher - Published 22 November 2016

The US Food and Drug Administration (FDA) sent a warning letter to Wockhardt Limited founder Habil Khorakiwala last week over good manufacturing practice (GMP) violations at the company's CP Pharmaceuticals subsidiary in Wrexham, UK.

Categories: News, Europe, US, FDA, Compliance, Drugs, Manufacturing

Tags: Aseptic Processing, Warning Letter

Regulatory Recon: PhRMA CEO: Don't Blame Pharma Companies; Novartis Acquires Selexys in $665M Deal (21 November 2016) By Michael Mezher - Published 21 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

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 Update to ICH Pediatric Clinical Trials Guidance By Michael Mezher - Published 21 November 2016

The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials.

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

Tags: Pediatric drug development, ICH E11

Regulatory Recon: Chicago to License Pharma Sales Reps to Curb Opioid Overprescribing; WHO Secures Funds for Malaria Vaccine Pilot (18 November 2016) By Michael Mezher - Published 18 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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 Highlights Ongoing Challenges in Oversight of Drug Compounders By Michael Mezher - Published 18 November 2016

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

Categories: News, US, FDA, Communication, Drugs, Manufacturing

Tags: Drug Compounding, Outsourcing Facility, Government Accountability Office, GAO

Regulatory Recon: FDA Approves Intrarosa for Pain During Sex for Postmenopausal Women (17 November 2016) By Michael Mezher - Published 17 November 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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 Looks to Revamp GCP Guidelines, Adds New Members By Michael Mezher - Published 17 November 2016

Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week.

Categories: News, Anvisa, ICH, MFDS, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: ICH, International Council for Harmonisation, Good clinical practice, GCP, Real world evidence

FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance.

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

Tags: Essure, Boxed warning, Patient decision checklist

FDA Warns Japanese API Maker Over Data Integrity Issues By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site.

Categories: News, Japan, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Data integrity