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Regulatory Recon: Merck Hit in Global Ransomware Attack; Califf Shares Ideas on Real World Evidence (28 June 2017) By Michael Mezher - Published 28 June 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: Merck Cholesterol Drug Surprises With Phase III Success; Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 2017) By Michael Mezher - Published 27 June 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

AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: News, US, FDA, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, ICH, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

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

Tags: generic drugs, priority review of generics, drug price competition, drug prices

GAO: FDA Needs a Plan for GDUFA Carryover Fees By Michael Mezher - Published 27 June 2017

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO

House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017 By Zachary Brennan - Published 27 June 2017

The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration.

Categories: News, US, FDA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: FDA FY 2018, FDA budget, FDA appropriations

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse By Michael Mezher - Published 26 June 2017

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Generic Competition

FDA, NCI to Collaborate Further on Cancer Research By Zachary Brennan - Published 26 June 2017

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: News, US, CDRH, Combination products, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: National Cancer Institute, proteogenomics, cancer research

Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017) By Michael Mezher - Published 26 June 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

Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations By Zachary Brennan - Published 26 June 2017

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: News, US, FDA, Clinical, Drugs, Medical Devices

Tags: CTTI, mobile technology and clinical trials, novel trial endpoints

FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years By Zachary Brennan - Published 26 June 2017

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

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

Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution

EMA Offers New EudraVigilance Checklist for Sponsors, MAHs By Zachary Brennan - Published 26 June 2017

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: News, Europe, EMA, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, marketing authorisation holders, individual case safety reports

Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017) By Michael Mezher - Published 23 June 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

Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure By Michael Mezher - Published 23 June 2017

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: Brexit, EMA Relocation

EMA Recommends New HCV, Cancer and MS Drugs for Approval By Michael Mezher - Published 23 June 2017

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: CHMP, Maviret, Vosevi, Imraldi

Senate Health Bill Would Repeal Device Tax By Michael Mezher - Published 22 June 2017

Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law.

Categories: News, Government affairs, Medical Devices

Tags: Medical Device Tax

European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017) By Nick Paul Taylor - Published 22 June 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: European Regulatory Roundup, Regulatory Roundup

Regulating CRISPR: FDA and Industry Offer Perspective By Zachary Brennan - Published 21 June 2017

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

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

Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics

Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017) By Michael Mezher - Published 21 June 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 Warns Chinese API Maker for Data Integrity Issues By Michael Mezher - Published 21 June 2017

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: Data Integrity

Gottlieb Looks to Boost Generic Drug Competition By Michael Mezher - Published 21 June 2017

As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Competition, Generic Drugs

Asia Regulatory Roundup: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (20 June 2017) By Nick Paul Taylor - Published 20 June 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests By Michael Mezher - Published 20 June 2017

At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

Categories: News, US, FDA, Generic drugs, Orphan products

Tags: FY2018 Budget, Appropriations, Orphan Drug Designations, REMS, Scott Gottlieb