Search Results for regulatory

Showing 1 – 25  of 1966

Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017) By Nick Paul Taylor - Published 20 November 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs

Tags: Asia Regulatory Roundup, online medicines in China, homeopathic

Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results; Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017) By Michael Mezher - Published 20 November 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 Votes No on Bayer's Inhaled Cipro; Takeda CEO Eyes Deals Outside Japan (17 November 2017) By Michael Mezher - Published 17 November 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: EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit (17 November 2017) By Nick Paul Taylor - Published 17 November 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, EU Regulatory Roundup

Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra; Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 2017) By Michael Mezher - Published 16 November 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: AstraZeneca Bags Approvals for Fasenra, Faslodex; Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017) By Michael Mezher - Published 15 November 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 Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017) By Michael Mezher - Published 14 November 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

Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017) By Nick Paul Taylor - Published 14 November 2017

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

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate By Zachary Brennan - Published 13 November 2017

New research published last week digs into cross-national regulatory divergences, with a focus on why some US labels for certain flu treatments say the medicines have not been proven to reduce complications while EU labels claim the opposite.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs

Tags: Relenza, Tamiflu, regulatory divergence

Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D; J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017) By Michael Mezher - Published 13 November 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 Dynavax's Hep B Vaccine; BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017) By Michael Mezher - Published 10 November 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: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals; FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017) By Michael Mezher - Published 09 November 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: Ohio Drug Pricing Ballot Initiative Fails; NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017) By Michael Mezher - Published 08 November 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

Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update By Gloria Hall - Published 07 November 2017

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling.

Categories: Features, Advertising and Promotion, Labeling, Nutritional and dietary supplements

Tags: Regulatory Focus, Feature Articles, Editorial

Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers; Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017) By Michael Mezher - Published 07 November 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: Valeant to Sell Sprout Back to Former Owners; Novartis Submits Kymriah for EU Review (6 November 2017) By Michael Mezher - Published 06 November 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 Valeant's Glaucoma Drug Vyzulta; Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017) By Michael Mezher - Published 03 November 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: Teva Warns on Profit Outlook; Hospitals Vow to Keep Medicare Drug Subsidies (2 November 2017) By Zachary Brennan - Published 02 November 2017

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

Categories: News, Canada, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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

Regulatory Recon: Bayer, Novartis Fight With UK Doctors Over Avastin Use for AMD; OPDP Enforcement Letters at Record Low (1 November 2017) By Michael Mezher - Published 01 November 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

Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017) By Nick Paul Taylor - Published 31 October 2017

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

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, autologous cell products, surgical mesh

Regulatory Recon: States Seek to Expand Generic Price Fixing Suit to 18 Companies; Pfizer Beats Profit Estimates in Q3 (31 October 2017) By Michael Mezher - Published 31 October 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 to Buy French Drugmaker AAA for $3.9B; Merck Withdraws EU Application for Keytruda in NSCLC (30 October 2017) By Michael Mezher - Published 30 October 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: CVS Makes $66B Bid for Aetna; Endo Sues FDA Over Compounding Rules (27 October 2017) By Michael Mezher - Published 27 October 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: Purdue Under Investigation Over OxyContin Claims; GSK to Build EU Drug Testing Facility as Brexit Contingency (26 October 2017) By Michael Mezher - Published 26 October 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: GSK Eyes Pfizer, Merck Consumer Units; Sanofi Sues Mylan Over Insulin Pen (25 October 2017) By Michael Mezher - Published 25 October 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