Search Results for FDA

Showing 1 – 25  of 1573

FDA Offers Draft Guidance to Further Secure Drug Supply Chain By Zachary Brennan - Published 21 August 2017

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging, Regulatory strategy

Tags: DSCSA, track and trace, FDA guidance, drug supply chain

Regulatory Recon: Samsung Bioepis and Takeda Team Up for Biologics Development; Hikma Raises Prices of Six US Generics (21 August 2017) By Michael Mezher - Published 21 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 Explainer: FDA User Fee Reauthorizations From 2018 to 2022 By Zachary Brennan - Published 21 August 2017

President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDARA, FDA user fees, user fee reauthorization, medical product reviews

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

Categories: News, US, FDA, Biologics and biotechnology, Clinical

Tags: PREA, FDASIA, non-compliance letters FDA

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

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

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

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

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

FDA Offers More Details on Digital Health Precertification Pilot By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the roll out of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participants.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, precertification pilot for digital health, FDA digital health

Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: MDDT, medical device development tools, FDA guidance

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

Proposed and Final FDA Rules: What’s Left in 2017 By Zachary Brennan - Published 08 August 2017

The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

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

Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance By Zachary Brennan - Published 08 August 2017

With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.

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

Tags: expiration date, FDA draft guidance, repackaging

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

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

Trump to Sign FDA User Fee Reauthorization Bill By Zachary Brennan - Published 03 August 2017

Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. A spokesman for President Donald Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”

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

Tags: FDA user fees, FDA user fee reauthorization

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

Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess By Zachary Brennan - Published 01 August 2017

Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the bipartisan US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week.

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

Tags: FDA user fees, BsUFA, GDUFA, PDUFA, MDUFA, drug prices, Medicare

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