Drug, Supplement Industries Need Formal But Timely Guidance - Stakeholders
This article was originally published in The Tan Sheet
Executive Summary
Food and drug industry stakeholders suggest FDA clarify regulatory expectations and justify requirements through written and finalized formal guidance rather than through speeches and other informal communications
You may also be interested in...
Information Disclosure Issues Challenge FDA Transparency Task Force
FDA questions whether to disclose information on product applications that a company abandons before approval or in some cases on applications in which review is still pending
Final AER Guidance Requires Full Address, Recommends Prefatory Language
In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs
Supplement Industry Wants Answers From FDA Transparency Task Force
Supplement industry leaders want FDA's Transparency Task Force to shed light on the agency's decision-making process and explain controversial and ambiguous policies as well as improve communication