Search Results for Michael Mezher

Showing 1 – 25  of 934

FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles By Michael Mezher - Published 24 April 2017

In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline.

Categories: News, US, FDA, Drugs

Tags: Doxycycline, Medical Countermeasures, MCM, Anthrax

Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 2017) By Michael Mezher - Published 24 April 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: Google's Verily to Launch 10,000 Patient 'Baseline' Study; WHO, Gates Underscore Progress Against NTDs (19 April 2017) By Michael Mezher - Published 19 April 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 Roche's Tecentriq for Advanced Bladder Cancer; Cardinal Health to Buy Medtronic Ops for $6.1B (18 April 2017) By Michael Mezher - Published 18 April 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

TGA to Move Forward With Orphan Drug Revamp By Michael Mezher - Published 18 April 2017

Australia's pharmaceutical industry is "broadly supportive" of proposed changes to the country's orphan drug program, the Therapeutic Goods Administration (TGA) says.

Categories: News, Oceania, TGA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Orphan Drugs, Australia

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

Regulatory Recon: OncoMed Lung Cancer Drug Fails in Phase II Study; Hanmi Charged for Late Reporting of Fatal Side Effect (17 April 2017) By Michael Mezher - Published 17 April 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: Lilly, Incyte RA Drug Baricitinib Rejected; FDA Ends REMS Requirement for Amgen Anemia Drugs (14 April 2017) By Michael Mezher - Published 14 April 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 Updates Guidance on Clinical Data Publication Policy By Michael Mezher - Published 14 April 2017

The European Medicines Agency (EMA) on Wednesday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect last fall.

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

Regulatory Recon: Neurocrine Biosciences' Ingrezza Approved for Tardive Dyskinesia; FDA's Pazdur Discusses New Oncology Center (12 April 2017) By Michael Mezher - Published 12 April 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

Fast Start for FDA Drug Approvals in 2017 By Michael Mezher - Published 12 April 2017

The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015.

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

Tags: Approvals, New Molecular Entities, Biologics License Applications

Regulatory Recon: NICE Says No to BMS' Opdivo for Head and Neck Cancer; SEC Targets Fake Biotech Stock News (11 April 2017) By Michael Mezher - Published 11 April 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

AdvaMed CEO Confident of Device Tax Repeal This Year By Michael Mezher - Published 11 April 2017

The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: AdvaMed, Medical Device Tax, Inspections

PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals By Zachary Brennan, Michael Mezher - Published 11 April 2017

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.

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

Tags: First Cycle Reviews, PhRMA, PDUFA V, PDUFA VI

EMA Looks to Revise Guideline on Investigation Drug Interactions By Michael Mezher - Published 10 April 2017

The European Medicines Agency (EMA) has proposed to change the agency's guideline for investigating drug interactions.

Categories: News, Europe, EMA, Drugs

Tags: drug-drug interaction, drug-food interaction

Regulatory Recon: David Hung Steps in as Axovant CEO; Stada to Support €4.1B Takeover Offer from Bain Capital and Cinven (10 April 2017) By Michael Mezher - Published 10 April 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 Delays eCTD Requirements for Master Files By Michael Mezher - Published 07 April 2017

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.

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

Tags: drug master files, biological product file, DMF, BPF, electronic common technical document, eCTD

EMA Completes Postmarket Safety Review of Uptravi By Michael Mezher - Published 07 April 2017

Less than two months after launching a safety review of Actelion Pharmaceuticals' pulmonary arterial hypertension (PAH) drug, Uptravi (salexipag), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) says it did not find an increased risk of death associated with the drug.

Categories: News, Europe, EMA, Prescription drugs, Postmarket surveillance

Tags: Uptravi, salexipag, PRAC

Regulatory Recon: FDA Rejects Merck's Bid to Add Heart Data to Januvia Label; Two Gilead HCV Drugs Approved for Pediatric Use (7 April 2017) By Michael Mezher - Published 07 April 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

EU Parliament Adopts New Medical Device, IVD Regulations By Michael Mezher - Published 05 April 2017

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: MDR, IVDR, European Parliament

Regulatory Recon: FDA Approves Teva's Huntington's Drug Austedo; Califf Speaks Out Against Trump Budget Proposal (4 April 2017) By Michael Mezher - Published 04 April 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

Cybersecurity: House Committee Looks to Build on Public-Private Partnerships By Michael Mezher - Published 04 April 2017

The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector.

Categories: News, US, FDA, Medical Devices

Tags: Cybersecurity, Information Sharing and Analysis Centers, ISACs, NH-ISAC, House Energy & Commerce

Regulatory Recon: Astellas to Buy Belgian Drug Discovery Co Odega for €500M; BMS Says Immunotherapy Combo Extends Survival in Melanoma (3 April 2017) By Michael Mezher - Published 03 April 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 Adopts Updated Guideline on Fixed Dose Combination Drugs By Michael Mezher - Published 03 April 2017

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) last week adopted an updated guideline on clinical development for fixed combination drugs, which is expected to take effect in October.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs

MHRA to No Longer Require Payment in Advance for License Applications By Michael Mezher - Published 31 March 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced changes to how it handles payments for license applications for drugs and clinical trials.

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

Tags: Fees, Payment