Page 10 - Docket Number News Today

Clinical/Antimicrobial

The agency is seeking public comment until October 30

This guidance outlines FDA's current policies and procedures for civil money penalties (CMPs) and no-tobacco-sale orders (NTSOs) for retailers.

Procedural

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

CMC

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies

Informed Consent Information Sheet - Draft Guidance

Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

Guidance provides applicants and manufacturers of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake (AI) limits