Search Results for Regulatory

Showing 1 – 25  of 1877

Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

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

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

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

European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017) By Nick Paul Taylor - Published 17 August 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

Tags: European regulatory roundup, Ireland biosimilars, CROs

RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals By Zachary Brousseau - Published 16 August 2017

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs

Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer; South Carolina Sues Purdue Over Opioid Marketing (16 August 2017) By Michael Mezher - Published 16 August 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: Early Looks at Trial Results Giving Investors Whiplash; Biosimilars Still Hard to Sell Against Rivals (15 August 2017) By Michael Mezher - Published 15 August 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: No Manufacturers Have Complied With India's GMP Request (15 August 2017) By Nick Paul Taylor - Published 15 August 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, Medical Devices

Tags: Asia Regulatory Roundup, DCGI, GMP/GLP

Regulatory Recon: FDA Restricts Foreign Scientist Hirings; Trump Blasts Merck CEO for Quitting Council (14 August 2017) By Michael Mezher - Published 14 August 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: Trump Labels Opioid Crisis a National Emergency; FDA Warns of Deaths With Intragastric Balloons (11 August 2017) By Michael Mezher - Published 11 August 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

192 Earned Regulatory Affairs Certification (RAC) in Spring 2017 By Zachary Brousseau - Published 10 August 2017

RAPS congratulates the 192 regulatory professionals who earned Regulatory Affairs Certification (RAC) during the recent spring 2017 exam period.

Categories: HTML, Articles, Under RAPS, RAC

Tags: RAC, Regulatory Affairs Certification

Regulatory Recon: Grail Sees Hope for Liquid Biopsy; Study Finds Heart Drug Prescribing Slashed After Price Hikes (10 August 2017) By Michael Mezher - Published 10 August 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: SoftBank Bets $1.1B on US Biotech Roivant; Mylan Delays Product Launches Over Uncertainty (9 August 2017) By Michael Mezher - Published 09 August 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: Kite CAR-T Drug Gets a Pass on Advisory Committee Review; FDA Again Rejects Valeant Glaucoma Drug Over Manufacturing Issues at Florida Site (8 August 2017) By Michael Mezher - Published 08 August 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 Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017) By Nick Paul Taylor - Published 08 August 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, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Asia Regulatory Roundup, China guidance

Regulatory Recon: MyoKardia Plots Course After Phase II Success; How PBMs Maintain EpiPen Market Share Despite Generic Alternatives (7 August 2017) By Michael Mezher - Published 07 August 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: BMS to Acquire IFM Therapeutics in $2.3B Deal; FDA Approves AbbVie's 8-Week Pan-Genotypic Hep C Drug (4 August 2017) Published 04 August 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 Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017) By Nick Paul Taylor - Published 03 August 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: European regulatory roundup, drugs for older people, radiopharmaceuticals

Regulatory Recon: Jazz Pharmaceuticals' Vyxeos Approved for High Risk AML; FDA Panel Votes Down J&J's Sirukumab on Safety Concerns (3 August 2017) By Michael Mezher - Published 03 August 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: India Plans Crackdown on Drug Promotion; Daiichi Sankyo Offers $300M to Settle US Benicar Suits (2 August 2017) By Michael Mezher - Published 02 August 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 Celgene's Targeted AML Drug Idhifa; Vertex Picks Up Expanded Indication for Kalydeco (1 August 2017) By Michael Mezher - Published 01 August 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 Ways to Get the Most From RAPS' Regulatory Convergence By Zachary Brousseau - Published 01 August 2017

Attending RAPS' Regulatory Convergence conference is an investment in your job, your career and your regulatory knowledge. To get the most out of it, you will want to think a little bit about how best to spend your precious time.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose

Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August By Gloria Hall - Published 01 August 2017

Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.

Categories: Features, Career Development

Tags: Features, Regulatory Focus

Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017) By Nick Paul Taylor - Published 01 August 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, medical device regulations, online regulatory filing

Regulatory Recon: Kite Submits First CAR-T Application in Europe; FDA Reviewers Raise Safety Concerns for J&J's RA Drug Sirukumab (31 July 2017) By Michael Mezher - Published 31 July 2017

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

Categories: News, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Regulatory intelligence

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

Regulatory Recon: Merck Says June Cyber Attack Led to Lower Guidance; Roche Leukemia Drug Picks Up Breakthrough Designation (28 July 2017) By Michael Mezher - Published 28 July 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 Immunotherapy Fails in Lung Cancer Study; FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017) By Michael Mezher - Published 27 July 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