Search Results for Regulatory

Showing 1 – 25  of 1821

Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017) By Michael Mezher - Published 23 June 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: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017) By Nick Paul Taylor - Published 22 June 2017

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

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

Tags: European Regulatory Roundup, Regulatory Roundup

Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017) By Michael Mezher - Published 22 June 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: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017) By Michael Mezher - Published 21 June 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:  Pamplona to Buy CRO Parexel for $5B; FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017) By Michael Mezher - Published 20 June 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: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (20 June 2017) By Nick Paul Taylor - Published 20 June 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

Tags: Asia Regulatory Roundup, Regulatory Roundup

Regulatory Recon: Seattle Genetics Halts Trials Due to Patient Deaths; Novartis' Rituxan Biosimilar Gets EU Approval (19 June 2017) By Michael Mezher - Published 19 June 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: Adamis Wins FDA Approval for EpiPen Rival; BMS to Sell Ireland API Plant to SK Biotek (16 June 2017) By Michael Mezher - Published 16 June 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: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017) By Nick Paul Taylor - Published 15 June 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, ENVI, antibiotics, PRAC

Regulatory Recon: Google, Novartis Back Medicxi's $300M Biotech Fund; China's Rise in Biotech (15 June 2017) By Michael Mezher - Published 15 June 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: NICE Rejects Pfizer's Besponsa for ALL; Sanofi to Increase Investment in Biologics Production (14 June 2017) By Michael Mezher - Published 14 June 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

Caribbean Regulatory System Begins Recommending Generic Drugs By Zachary Brennan - Published 14 June 2017

The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments.

Categories: News, Latin America and Caribbean, FDA, WHO, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Caribbean medicines, Caribbean drug regulators, WHO, PAHO, Caribbean Regulatory System

Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017) By Nick Paul Taylor - Published 13 June 2017

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

Categories: News, Asia, CDSCO, CFDA, Crisis management, Drugs, Government affairs

Tags: Asia Regulatory Roundup, India clinical trials, CFDA guidance

Regulatory Recon: Merck Pauses Two Keytruda Studies After Patient Deaths; Pfizer, Roche & Aspen Face South Africa Pricing Probe (13 June 2017) By Michael Mezher - Published 13 June 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

ICH Expands MedDRA's Uptake Globally By Michael Mezher - Published 12 June 2017

The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA.

Categories: News, ICH

Tags: ICH, MedDRA, Medical Dictionary for Regulatory Activities

Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar; Chi-Med Seeks CFDA Approval for Cancer Drug (12 June 2017) By Michael Mezher - Published 12 June 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: Japan Scraps Drug Price Cut Proposal; NICE Rejects Zurampic for Hyperuricemia in Gout Patients (9 June 2017) By Michael Mezher - Published 09 June 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: EMA to Discuss Improving Treatment of Kids With Lymphoma, Leukemia (8 June 2017) By Nick Paul Taylor - Published 08 June 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

Tags: European Regulatory Roundup, BASG, BfArM

Regulatory Recon: Valeant to Sell Pharma Unit for $930M; South Korea to Fine Novartis Over Drug Promos (8 June 2017) By Zachary Brennan - Published 08 June 2017

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

Categories: News, Asia, Europe, US, EC, FDA, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss; Trump Will Keep Collins as NIH Director (7 June 2017) By Michael Mezher - Published 07 June 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

Global Harmonization Initiatives, FDA's User Fee Programs, Pediatric Legislation, Conditional Approvals, Quality Certificates and a Preview of June By Gloria Hall - Published 06 June 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 June.

Categories: Features, EMA, FDA, Health Canada, ICH, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration

Tags: Regulatory Focus, Feature Articles

Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday; FDA Approves Valve-in-Valve Use for Edwards' Sapien 3 Valves (6 June 2017) By Michael Mezher - Published 06 June 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: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017) By Michael Mezher - Published 05 June 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, ASCO, ASCO17

Regulatory Recon: ViiV, GSK Use Priority Review Voucher for 2-Drug HIV Combo; NICE Backs Opdivo for Classical Hodgkin Lymphoma (2 June 2017) By Michael Mezher - Published 02 June 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