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Filtering on: "topics regulatory intelligence"

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Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives; ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017) By Michael Mezher - Published 17 January 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 Promises 'Insurance for Everybody'; FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017) By Michael Mezher - Published 16 January 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 Meets With Silicon Valley Insiders for FDA Pick; Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017) By Michael Mezher - Published 13 January 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FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: News, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: RLD, generic drugs, ANDA, ANDA submission

Testing and Implementing a Web-Based, Country Regulatory Information Management System By Elizabeth Rehfeld - Published 13 January 2017

This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.

Categories: Features, Project management, Regulatory intelligence

Tags: Information management, Regulatory information management system

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

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

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

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

Tags: 180-day exclusivity, generic drugs, FDA guidance

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

Regulatory Recon: Trump Meets with NIH Contenders; NICE Backs Novartis Kidney Cancer Drug (12 January 2017) By Michael Mezher - Published 12 January 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

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

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

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

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

Tags: foreign drug inspections, foreign device inspections

Regulatory Recon: Merck Gambles on Early sBLA for Keytruda Combo; FDA Accepts BLA Mylan & Biocon's Proposed Biosimilar Trastuzumab (11 January 2017) By Michael Mezher - Published 11 January 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’s Approval of a New Abuse-Deterrent Opioid Raises Questions By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties.

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

Tags: opioid, opioid abuse, marketing exclusivity, FDA drug approval, abuse-deterrent opioid

FDA Offers Final Guidance on CGMP Requirements for Combo Products By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.

Categories: News, US, FDA, Combination products, Regulatory intelligence, Regulatory strategy

Tags: CGMP, combo products, FDA guidance

Regulatory Recon: Highly-Valued Moderna Hits Safety Problems with Lead Drug; HHS Secretary Calls for Medicare to Negotiate Drug Prices (10 January 2017) By Michael Mezher - Published 10 January 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, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl By Zachary Brennan - Published 09 January 2017

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015.

Categories: News, US, DOJ, FDA, Advertising and Promotion, Drugs, Regulatory intelligence

Tags: Galena, DOJ, Abstral, fentanyl marketing

Regulatory Recon: Takeda Buys Ariad for $5.2 Billion; Merrimack to Sell Oncology Assets to Ipsen (9 January 2017) By Michael Mezher - Published 09 January 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

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

Regulatory Recon: CDC Hid Numerous Mishaps With Deadly Germs; High Priced Drugs to Blame for Rise in Medicare Part D Spending (5 January 2017) By Michael Mezher - Published 05 January 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

Mammogram Record Retention: FDA Offers Advice By Zachary Brennan - Published 05 January 2017

Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Categories: News, US, CDRH, Crisis management, Medical Devices, Quality, Regulatory intelligence

Tags: mammogram, FDA and mammography, MQSA

European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016) By Nick Paul Taylor - Published 05 January 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, European Regulatory Roundup, notified bodies, Braille

Regulatory Recon: Texas Sues FDA Over Death Penalty Drugs; Head of FDA's Criminal Office Departs (4 January 2017) By Michael Mezher - Published 04 January 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

New FDA Drug Approvals: Breaking Down the Numbers By Zachary Brennan - Published 04 January 2017

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: new drug approvals, pharmaceutical approvals, FDA approval

Regulatory Recon: Catch Up on All the News You Missed Over the Holidays (3 January 2017) By Michael Mezher - Published 03 January 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