Search Results for

Filtering on: "organizations agencies/organizations fda"

Showing 1 – 25  of 3748

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

Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' By Zachary Brennan - Published 22 September 2017

A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster reviews for generic drugs.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Tags: Pre-submission facility guidance, FDA draft guidance, priority generic drug reviews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FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars By Zachary Brennan - Published 21 September 2017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and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that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

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

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

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

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

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

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

Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Steps in to Regulate Microneedling Devices By Michael Mezher - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation.

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: Microneedling, Micro-needling, Draft Guidance

FDA Transparency: Gottlieb Outlines What’s Coming By Zachary Brennan - Published 14 September 2017

FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Scott Gottlieb, CRL transparency, REMS

FDA Approves First Biosimilar Cancer Treatment By Zachary Brennan - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen's biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).

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

Tags: Amgen, Mvasi, Avastin biosimilar

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018 By Zachary Brennan - Published 14 September 2017

With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs.

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

Tags: BsUFA, PDUFA, FDA user fees 2018

FDA Finalizes HPV Diagnostic Study Guidance By Michael Mezher - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer.

Categories: News, US, FDA, In vitro diagnostics

Tags: HPV, Human Papillomavirus, Cervical Cancer

FDA Draft Guidance for Medical Product Communications By Alan Bergstrom - Published 13 September 2017

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."

Categories: Features, FDA, Communication, Labeling

Tags: Communication, Labeling

Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake By Zachary Brennan - Published 13 September 2017

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.

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

Tags: biosimilars, interchangeable biosimilars

Congress Takes First Look at User Fee Program for OTC Drugs By Michael Mezher - Published 13 September 2017

The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products.

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

Tags: OTC Monograph, OMOR, Over-the-Counter Monograph, User Fees

FDA Plans to Finalize 510(k) Change Guidances Ahead of November Deadline By Michael Mezher - Published 13 September 2017

An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: 510(k) changes, 510(k) modification, Software

Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance By Zachary Brennan - Published 12 September 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

Categories: News, US, FDA, Drugs, Government affairs, Preclinical, Research and development

Tags: radiopharmaceuticals, nonclinical recommendations, FDA draft guidance

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials