Search Results for FDA

Showing 1 – 25  of 1677

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

FDA Begins Adding Suffixes to Newly Approved Biologics' Names By Zachary Brennan - Published 17 November 2017

The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in its previous policy of only adding the suffixes to biosimilars.

Tags: nonproprietary name, FDA biologics naming, naming policy for medicines

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

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

FDA Unveils New Regenerative Medicine Framework By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regenerative medicine, RMAT, FDA guidance

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

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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: 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

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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

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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 Warns Chinese Firm for Confusing API in OTC Drug By Zachary Brennan - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs made the firm was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: hydrocortisone, China API manufacturing, FDA warning letter

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

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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: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included By Zachary Brennan - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

Categories: News, US, FDA, Over the counter drugs, Labeling

Tags: aspirin, FDA label, cardiovascular images

FDA Finalizes Guidance on Developing DAA Drugs to Treat Hepatitis C Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday finalized draft guidance on developing direct-acting antiviral (DAA) drugs to treat Hepatitis C after revising the guidance twice.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: DAA drugs, Hepatitis C, FDA guidance

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

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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

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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

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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: 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

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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 to Recognize 8 EU Regulators to Conduct GMP Inspections By Zachary Brennan - Published 31 October 2017

The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing

Tags: FDA and EMA mutual recognition, GMP inspections, MRA

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

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

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

De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014 By Zachary Brennan - Published 27 October 2017

Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: de novo request, FDA guidance, de novo device

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