Search Results for intended use

Showing 1 – 3

FDA Delays Final Rule on Intended Uses By Michael Mezher - Published 17 March 2017

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

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

Tags: Intended Use, Final Rule, Totality of Evidence

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

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

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

How an FDA Proposed Rule for Tobacco Products Could Have a Big Impact on 'Intended Uses' for Devices, Drugs By Zachary Brennan - Published 19 October 2015

Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices.

Categories: Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: intended use, medical device, regulatory, drug, FDA proposed rule