Search Results for FDA rule

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FDA Delays Implementing Parts of 'Intended Use' Rule By Zachary Brennan - Published 12 January 2018

Confusion and concerns over portions of a tobacco-related final rule that could have major ramifications for the medical product industries has pushed the US Food and Drug Administration (FDA) to delay the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used.

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

Tags: intended use, First Amendment, FDA rule

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate By Zachary Brennan - Published 19 May 2016

The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts.

Categories: News, FDA, Biologics and biotechnology, Drugs, Government affairs, Labeling

Tags: generic drug labels, FDA rule, Public Citizen, adverse events

Proposed Rule Would Revise Regulations on Fixed-Combination Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients.

Categories: Biologics and biotechnology, Business Skills, Clinical, Combination products, Compliance, Drugs, Ethics, Government affairs, Labeling, Orphan products, Packaging, Preclinical, Project management, Regulatory strategy, Submission and registration

Tags: fixed-combination drugs, FDA rulemaking, proposed FDA rule, OTC drug monographs, nonprescription drug combinations