Withdrawn and Expired Guidances | Drugs

An alphabetical list of withdrawn or expired guidances related to drugs.

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Title	Date Issued	Date Withdrawn
Accelerated Approval Products —Submission of Promotional Materials	03/26/1999	05/06/2015
Acceptance of Foreign Clinical Studies	3/01/2001	12/06/2019
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment	07/22/1998	08/07/2013
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment	07/22/1998	08/07/2013
Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling	01/12/1998	10/21/2016
Analgesic Indications: Developing Drug and Biological Products	02/05/2014	06/20/2019
Analgesic Indications: Developing Drugs and Biological Products	2/14/2014	08/23/2019
Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children)	04/01/1988	05/29/2008
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals	06/12/2015	11/18/2016
Attachment D – Application, Product, and Establishment Fees: Common Issues and Their Resolution	12/16/1994	11/08/2017
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Information	02/01/2001	06/01/2006
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment	07/22/1998	08/07/2013
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment	07/22/1998	08/07/2013
Cholestyramine Powder In Vitro Bioequivalence	01/15/1993	03/01/2012
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft)	05/19/2016	03/26/2018
Classifying Resubmissions in Response to Action Letters	05/14/1998	05/27/2016
Classifying Significant Postmarketing drug safety issues	3/01/2012	4/20/2020
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis	07/15/1999	08/22/2018
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry	01/23/2020	11/05/2024
Clinical Evaluation of Antacid Drugs	04/01/1978	07/20/2004
Clinical Evaluation of Antidiarrheal Drugs	09/01/1977	07/20/2004
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs	09/01/1977	07/20/2004
Clinical Evaluation of Laxative Drugs	04/01/1978	07/20/2004
Clinical Evaluation of Lipid – Altering Agents	08/14/1998	04/16/2010
Clinical Evaluation of Radiopharmaceutical Drugs	10/01/1981	07/20/2004

Showing 1 to 25 of 160 entries