Search Results for FDA

Showing 1 – 25  of 1702

Regulatory Recon: FDA Lifts Hold on Alnylam Hemophilia Trials; EMA Recommends 7 New Medicines for EU Approval (15 December 2017) By Michael Mezher - Published 15 December 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: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients; Teva to Cut 14,000 Jobs (14 December 2017) By Michael Mezher - Published 14 December 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 Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017) By Michael Mezher - Published 13 December 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 Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 2017) By Michael Mezher - Published 12 December 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

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse to file, NDA, BLA, FDA draft guidance

FDA Finalizes Guidance on Promotional Drug Labeling and Ads By Zachary Brennan - Published 11 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads

Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 2017) Published 11 December 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 Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017) By Michael Mezher - Published 08 December 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

Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance By Zachary Brennan - Published 08 December 2017

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.

Categories: News, US, FDA, Generic drugs

Tags: ANDA amendments, FDA draft guidance

Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 2017) By Michael Mezher - Published 07 December 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 Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts By Zachary Brennan - Published 06 December 2017

The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells

FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing.

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

Tags: toxicology, FDA toxicology working group

Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 2017) By Michael Mezher - Published 06 December 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

More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

Categories: News, US, EMA, FDA, Clinical, Drugs

Tags: rare pediatric disease, Gaucher, FDA draft guidance

Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 2017) By Michael Mezher - Published 05 December 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 Finalizes Chagas Disease Guidance for Blood Collection Establishments By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi, a parasite that causes Chagas Disease, in blood and blood components.

Categories: News, US, CBER, Blood, Compliance

Tags: Chagas Disease, blood collection, FDA guidance

Regulatory Recon: CVS to Buy Aetna for $69B; FDA Approves Heart Protection Claims for Amgen's Repatha (4 December 2017) By Michael Mezher - Published 04 December 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 Finalizes Guidance to Help CMS With Coverage Decisions on Devices By Zachary Brennan - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMS coverage of medical devices, FDA guidance

Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal; National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017) By Michael Mezher - Published 01 December 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 Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology

Tags: Herceptin, biosimilar, FDA approval

Regulatory Recon: Promising Phase III Results for Novartis, Teva Migraine Drugs; Sanofi Expects $120m Hit Over Dengue Vaccine Safety Issues (30 November 2017) By Michael Mezher - Published 30 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: Melinta Buys Medicines Co's Infectious Disease Business; Bluebird Buys Facility to Make Viruses for Gene Therapy Delivery (29 November 2017) By Michael Mezher - Published 29 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: Gilead Prices Sovaldi in China at One Fifth US Cost; NICE Turns Down Early Use of Eisai's Halaven (28 November 2017) By Michael Mezher - Published 28 November 2017

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

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

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

FDA Warns, Blocks Imports From Chinese API Manufacturer By Zachary Brennan - Published 27 November 2017

Earlier this month, the US Food and Drug Administration (FDA) sent a warning letter to a Hubei, China-based active pharmaceutical ingredient (API) manufacturer related to several failures.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance

Tags: FDA warning letter

Regulatory Recon: Merck to Invest £1B in New UK Research Hub; Teva Overhauls Management in Restructuring Effort (27 November 2017) By Michael Mezher - Published 27 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