fbpx
May 8, 2020

CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Guidance for FDA staff and Industry CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and […]
May 8, 2020

CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections

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 […]
May 8, 2020

CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy BACKGROUND: The House Subcommittee on Oversight and Investigations began an investigation […]
May 8, 2020

CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Pharmaceutical Quality BACKGROUND: In recent years the pharmaceutical industry has responded to an […]
May 8, 2020

Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies

Docket Number: FDA-2008-D-0180 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]
May 7, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020

For Immediate Release: May 07, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 7, 2020

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry

Docket Number: FDA-2013-D-0558 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]
May 7, 2020

Content and Format for Geriatric Labeling

Docket Number: FDA-1998-D-0037 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research In a final rule published in […]
May 7, 2020

Consumer Antiseptic Wash Final Rule Questions and Answers

Docket Number: FDA-2017-D-3906 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses better understand and comply […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0