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Congress Sets Sights on Pharma Cybersecurity After Attack By Michael Mezher - Published 22 September 2017

Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector.

Categories: News, US, Biologics and biotechnology, Drugs

Tags: Cybersecurity, NotPetya, Petya, Energy & Commerce, Merck

FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies By Michael Mezher - Published 22 September 2017

A paper appearing in the New England Journal of Medicine on Thursday argues that the US Food and Drug Administration (FDA) is not doing enough to ensure drugmakers complete postmarketing studies required by the agency at the time their drugs are approved.

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

Tags: Postmarketing Requirements, Postmarketing study, FDAAA

Regulatory Recon: FDA Warns of Deaths From Incorrect Ocaliva Dosing; Versartis' Shares Plummet After Growth Hormone Fails in Phase III (22 September 2017) By Michael Mezher - Published 22 September 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

Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' By Zachary Brennan - Published 22 September 2017

A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster reviews for generic drugs.

Categories: News, US, FDA, Generic drugs, Government affairs, Manufacturing

Tags: Pre-submission facility guidance, FDA draft guidance, priority generic drug reviews

Public Citizen Sues FDA Over OTC Drug Risks By Michael Mezher - Published 21 September 2017

Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine.

Categories: News, US, FDA, Over the counter drugs

Tags: Benzocaine, Teething, Methemoglobinemia, Public Citizen, OTC Monograph

FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars By Zachary Brennan - Published 21 September 2017

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

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

Tags: biosimilar guidance, analytical similarity, FDA guidance

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias By Zachary Brennan - Published 21 September 2017

Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: EU ombudsman, early regulator engagement, pre-submission meetings

Regulatory Recon: EU Approves Merck, Pfizer's Bavencio; FDA Advises on Opioid Benzo Combo (21 September 2017) By Michael Mezher - Published 21 September 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

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

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

Tags: REMS, Hatch-Waxman, generic drug competition

FDA's Woodcock: The Clinical Trials System is 'Broken' By Zachary Brennan - Published 20 September 2017

The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

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

Tags: Janet Woodcock, real world evidence, real world data, drug development

FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

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

Tags: Expanded Access, Compassionate Use, Right-to-Try

Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 2017) By Michael Mezher - Published 20 September 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

Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars By Zachary Brennan - Published 20 September 2017

Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance on the US market for its blockbuster Remicade (infliximab) despite recently introduced competition.

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

Tags: Pfizer, J&J, infliximab, Remicade, Inflectra, Renflexis

Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017) By Nick Paul Taylor - Published 19 September 2017

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

Categories: News, Asia, CFDA, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup

FDA Warns Korean, Chinese Drugmakers By Zachary Brennan - Published 19 September 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

Categories: News, Asia, US, FDA, Drugs, Manufacturing

Tags: FDA warning letters, Wuxi Medical, Firson

Regulatory Recon: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 2017) By Michael Mezher - Published 19 September 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

Real World Evidence: FDA Commits to Advancing its Use By Zachary Brennan - Published 19 September 2017

To enable greater adoption of real world evidence (RWE) in clinical and regulatory decisions, FDA Commissioner Scott Gottlieb said Tuesday the agency will need to work with the healthcare system to change the way clinical information is collected.

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

Tags: real world evidence, Scott Gottlieb, clinical data

UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

Biomarker Qualification: FDA Explains Process and Opportunities for Engagement By Michael Mezher - Published 19 September 2017

In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.

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

Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures

EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes By Michael Mezher - Published 18 September 2017

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.

Categories: News, Europe, EMA, Biologics and biotechnology, Blood

Tags: Factor VIII, Inhibitor, Hemophilia A

Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 2017) By Michael Mezher - Published 18 September 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

Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations By Michael Mezher - Published 18 September 2017

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors.

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

Tags: Quantitative Benefit-Risk Assessment, ICH M4E(R2)

FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

Categories: News, US, CDRH, Clinical, Medical Devices

Tags: organ preservation, FDA draft guidance

Malaysia Issues Compulsory License for Gilead Hepatitis C Drug By Zachary Brennan - Published 15 September 2017

Late last month, Malaysia’s government issued a compulsory license in an effort to offer a less-expensive version of Gilead’s hepatitis C drug and increase access.

Categories: News, Asia, Drugs

Tags: Malaysia, Gilead, Hepatitis C, compulsory license