Search Results for regulatory

Showing 1 – 25  of 1791

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

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

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

Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017) By Nick Paul Taylor - Published 23 May 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017) By Zachary Brennan - Published 23 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Health Canada, TGA, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017) By Zachary Brennan - Published 22 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, US, FDA, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017) By Nick Paul Taylor - Published 18 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: European Regulatory Roundup, EU roundup of pharma news, Aspen, personalized medicine, ANSM

Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) By Zachary Brennan - Published 18 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Canada, Europe, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices

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

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

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 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: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

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

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

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

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

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

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

Regulatory Recon: Novartis, Roche Back French Gene Therapy Startup; Pfizer to Give Patients Free Access to Breast Cancer Drug as it Awaits NICE Decision (4 May 2017) By Michael Mezher - Published 04 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: Former FDA Commissioner Califf Offers Advice to Gottlieb; DoJ Raids Perrigo in Price Fixing Probe (3 May 2017) By Michael Mezher - Published 03 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

Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May By Gloria Hall - Published 02 May 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in May.

Categories: Asia, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Submission and registration

Tags: Features, Regulatory Focus

Regulatory Recon: AstraZeneca's Durvalumab Gets First Bladder Cancer Approval; Pfizer, Merck Beat Q1 Profit Estimates (2 May 2017) By Michael Mezher - Published 02 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