Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex […]

Docket Number: FDA-1996-D-0405 Issued by: Guidance Issuing Office Office of Inspections and Investigations Compliance Policy Guide Sec. 110.100 was withdrawn November 4, 2021 Issued: 10/01/1980Revised: 04/14/2000Withdrawn: […]

Issued by: Guidance Issuing Office Office of Inspections and Investigations Compliance Policy Guide Guidance for FDA staff and Industry CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Document Release Date: June 2, 2007 This document supersedes Compliance Policy Guide (CPG) “Sec. 130.300 FDA Access […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research, Office of Regulatory Policy BACKGROUND: The House Subcommittee on Oversight and […]

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Sec. 230.120- Human Blood and Blood Products As Drugs is obsolete and was withdrawn […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: A district compliance officer has inquired if a domestic distributor can take advantage of the immunity […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: On occasion, questions have been raised concerning FDA’s authority over foreign origin products brought into the […]