Search Results for Michael Mezher

Showing 1 – 25  of 979

EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25 By Michael Mezher - Published 26 May 2017

The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: PRIME, Priority Medicines

Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 2017) By Michael Mezher - Published 26 May 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 Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote By Michael Mezher - Published 25 May 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

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

Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar

Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug; Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 2017) By Michael Mezher - Published 25 May 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 Issues 483 to Repro-Med Over Reporting, Quality Systems Issues By Michael Mezher - Published 24 May 2017

The US Food and Drug Administration (FDA) has issued an inspection report detailing eight observations to medical device maker Repro-Med Systems following a seven-day inspection of the company's Chester, NY facility in late 2016.

Categories: News, US, FDA, Medical Devices

Tags: Form 483

Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug; Biogen MS Drug Fampyra Picks up Full EU Approval (24 May 2017) By Michael Mezher - Published 24 May 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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: House Committee Schedules FDA Budget Hearing; Janssen Sues to Block Samsung Bioepis' Remicade Biosimilar (19 May 2017) By Michael Mezher - Published 19 May 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 How Kalydeco's Indication Expanded Without New Clinical Data By Michael Mezher - Published 19 May 2017

For the first time, the US Food and Drug Administration (FDA) has expanded a drug's indication without additional clinical data.

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

Tags: Kalydeco, Cystic Fibrosis

FDA, Industry Look for Gaps in Cybersecurity By Michael Mezher - Published 18 May 2017

The US Food and Drug Administration (FDA) on Thursday kicked off a fortuitously-timed public workshop on medical device cybersecurity, the agency's third on the subject to date.

Categories: News, US, CDRH, Medical Devices

Tags: Cybersecurity, WannaCry

Regulatory Recon: Former FDA Commissioner Califf Gets New Role at Verily; FDA Puts Hold on Concert Hair Loss Drug Study (17 May 2017) By Michael Mezher - Published 17 May 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 Warns of False Results With Common Lead Test By Michael Mezher - Published 17 May 2017

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: Lead, Magellan Diagnostics, LeadCare

FDA Seeks Input on Device Accreditation Pilot By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions.

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

Tags: Accreditation Scheme for Conformity Assessment, ASCA, MDUFA IV, Consensus Standards

Regulatory Recon: Editas Delays CRISPR Cas9 Human Study; AstraZeneca Sues Former Exec After Leaving for GSK (16 May 2017) By Michael Mezher - Published 16 May 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 Issues New and Revised Guidance for Generic Drugs By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs.

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

Tags: Product-Specific Guidance, Bioequivalence

FDA Launches New ORA Structure to Align Inspections With Expertise By Michael Mezher - Published 15 May 2017

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

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

Tags: Program Alignment, Office of Regulatory Affairs, Inspections

Regulatory Recon: Thermo Fisher to Buy Patheon for $7.2B; EC Opens Formal Antitrust Investigation Into Aspen's Pricing Practices (15 May 2017) By Michael Mezher - Published 15 May 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 Keytruda in Combination with Chemo for Lung Cancer; Pfizer and Sangamo Strike Hemophilia Deal (11 May 2017) By Michael Mezher - Published 11 May 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: Roche's Tecentriq Fails in Phase III; PhRMA Cuts 22 Members (10 May 2017) By Michael Mezher - Published 10 May 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

UK Patients to Get Early Access to AbbVie's HCV Combo By Michael Mezher - Published 10 May 2017

Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

Categories: News, Europe, MHRA, Drugs, Submission and registration

Tags: EAMS, Early Access to Medicines Scheme, Glecaprevir, Pibrentasvir, AbbVie

FDA Blueprint for Opioid Education Shifts Focus to Pain Patients By Michael Mezher - Published 09 May 2017

As the US Food and Drug Administration (FDA) weighs its options for improving healthcare provider training and education on prescribing opioids, the agency is proposing changes to its blueprint for opioid prescriber education.

Categories: News, US, FDA, Drugs

Tags: Opioids

Regulatory Recon: J&J Discloses Federal Probes; House Committee Questions Companies, DEA Over Opioid Dumping in WV (9 May 2017) By Michael Mezher - Published 09 May 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 Warns Indian Firm for Impeding Inspection By Michael Mezher - Published 09 May 2017

The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

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

Tags: Inspection, Warning Letter

Regulatory Recon: FDA Approves First ALS Drug in Two Decades; Kite Discloses Patient Death in CAR-T Study (8 May 2017) By Michael Mezher - Published 08 May 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

CBER Director Focuses on Flexibility to Advance Regenerative Medicines By Michael Mezher - Published 08 May 2017

Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday said his office is equipped to support the development of cutting edge treatments, such as cell and gene therapies.

Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Regenerative Medicine, Cell and Gene Therapy, Advanced Therapies, RMAT Designation

Regulatory Recon: EMA, EC Release Biosimilars Information Guide; NICE Rejects Orexigen Weight-Loss Drug (5 May 2017) By Michael Mezher - Published 05 May 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