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Filtering on: "topics regulatory intelligence"

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Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017) By Michael Mezher - Published 18 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

Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

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

Tags: FDA inspections, contamination, sterile environments

Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017) By Nick Paul Taylor - Published 17 October 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, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, stem cells, black triangle

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee; GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017) By Michael Mezher - Published 16 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

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals By Zachary Brennan - Published 13 October 2017

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: cancer drug approvals, QoL, survival benefit

Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biotech Investment; NICE Backs Opdivo for Head and Neck Cancer (13 October 2017) By Michael Mezher - Published 13 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

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CRL, complete response letter, draft guidance

FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder By Zachary Brennan - Published 12 October 2017

Philadelphia-based Spark Therapeutics took its gene therapy before the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee on Thursday and the panel voted 16 to 0 in favor of approving the subretinal injection, representing a major step forward for adeno-associated virus gene therapies.

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

Tags: Spark Therapeutics, gene therapy, retinal disease, Luxturna

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: 505(b)(2) application, ANDA, FDA draft guidance

Regulatory Recon: Merck Ends Development of CETP Inhibitor; NIH to Team Up With 11 Drugmakers for Immunotherapy Research (12 October 2017) By Michael Mezher - Published 12 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

FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria By Zachary Brennan - Published 11 October 2017

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

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

Tags: Baxter, drug shortages, Puerto Rico, Hurricane Maria

REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

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

Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Regulatory Recon: Philips to Discontinue US Production of Some Defibrillators; Lupin Buys Symbiomix in $150M Deal (11 October 2017) By Michael Mezher - Published 11 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: Pfizer Weighs Sale of Consumer Health Business; FDA Releases Briefing Documents for Spark Gene Therapy (10 October 2017) By Michael Mezher - Published 10 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: CA Governor Expected to Sign Drug Price Transparency Bill; China Embraces Foreign Clinical Trial Data to Speed Approvals (9 October 2017) By Michael Mezher - Published 09 October 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: Bayer, J&J's Xarelto Fails Phase III Secondary Stroke Trial; Eli Lilly Beats Alimta Patent Challenge (6 October 2017) By Michael Mezher - Published 06 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

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision By Zachary Brennan - Published 06 October 2017

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: GDUFA II, ANDA status updates

Another Record Year for US Generic Drug Approvals in 2017 By Zachary Brennan - Published 05 October 2017

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

Categories: News, US, CDER, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug approvals, GDUFA, 2017 generic drug approvals

Regulatory Recon: US Court Reverses Praluent Sales Ban; Study Finds Most New Cancer Drugs Approved by EMA Don't Improve Survival (5 October 2017) By Michael Mezher - Published 05 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: Grassley Pushes for Drug Pricing Measures in CHIP Reauthorization; US Presses India on Device Price Caps (4 October 2017) By Michael Mezher - Published 04 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

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

Categories: News, Canada, Europe, US, FDA, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, common technical document, ICH guidance

FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing By Zachary Brennan - Published 03 October 2017

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Right-to-try, E&C Committee, Gottlieb, GAO, expanded access

Regulatory Recon: Shire Sues Allergan Over Restasis Contracts; Police Search Merck KGaAs French Facility in Thyroid Drug Inquiry (3 October 2017) By Michael Mezher - Published 03 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