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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Proposes Select Updates to the Breakthrough Devices Program Designed to Reduce Health Care Disparities

The FDA Law Blog

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

The FDA Law Blog

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

The FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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The Most Engaging Decision You’ll Read All Year – Five Stars

The FDA Law Blog

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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Stanford prof pays investors in defunct biotech Nuredis $29m

pharmaphorum

Dr Stanley Cohen was sued by Alafi Capital and the Christopher Alafi Family Trust – the only investors in Nuredis – in 2018. The lawsuit claimed he misled them whist persuading them to invest $20 million in the biotech, set up to develop a candidate therapy for neurodegenerative disease Huntington’s disease , in return for a 20% stake.

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FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

The FDA Law Blog

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”.

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