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  1. Guidance, Compliance, & Regulatory Information

Withdrawn Guidances (Drugs)

Withdrawn Guidances (Drugs)

Title Date Issued Date Withdrawn
Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information 12/29/2016 07/22/2019
Analgesic Indications: Developing Drug and Biological Products 02/05/2014 06/20/2019
Establishing Pregnancy Exposure Registries 08/01/2002 05/08/2019
In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies 12/30/1997 06/10/1999
 Attachment D – Application, Product, and Establishment Fees:  Common Issues and Their Resolution 12/16/1994 11/08/2017
New Drug Evaluation Guidance Document: Refusal to File 07/12/1993 05/19/2017
Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability 02/26/1999 02/03/2000
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment 05/16/2000 07/28/2010
Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records 11/12/2002 02/04/2003
Guideline for the Clinical Evaluation of Analgesic Drugs 12/01/1992 08/05/2003
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV 06/14/2002 11/21/2003
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 Radiopharmaceutical Drugs 10/01/1981 07/20/2004
FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer 06/01/1989 07/20/2004
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing 12/30/2003 04/01/2011
Preclinical Development of Antiviral Drugs 11/01/1990 07/06/2005
Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders 09/04/1992 12/29/2005
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence 03/09/2000 08/12/2005
Organization of an Abbreviated New Drug Application 03/02/1999 11/18/2005
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes:  Chemistry, Manufacturing, and Controls Information 02/01/2001 06/01/2006
Drug Product: Chemistry, Manufacturing, and Controls Information 01/01/2003 06/01/2006
Drug Substance: Chemistry, Manufacturing, and Controls Information 01/01/2004 06/01/2006
Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application 02/01/1987 06/01/2006
Stability Testing of Drug Substances and Drug Products 06/01/1998 06/01/2006
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides 11/01/1994 06/01/2006
Submitting Documentation for the Stability of Human Drugs and Biologics 02/01/1987 06/01/2006
Providing Electronic Submissions in Electronic Format - ANDAs 06/27/2002 09/29/2006
Providing Electronic Submissions in Electronic Format - NDAs 01/28/1999 09/29/2006
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs 08/28/2003 09/29/2006
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV 07/01/2004 07/05/2006
Clinical Evaluation of Weight-Control Drugs 09/01/1996 02/15/2007
Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children) 04/01/1988 05/29/2008
Labeling OTC Skin Protectant Drug Products 06/04/2003 08/04/2008
Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis 02/11/2004 12/02/2009
Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA 10/06/2003 04/09/2010
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA 11/22/2004 04/09/2010
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement 06/17/2003 04/09/2010
Clinical Evaluation of Lipid – Altering Agents 08/14/1998 04/16/2010
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) 12/04/2000 08/09/2010
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) 06/01/1998 10/17/2011
Consumer-Directed Broadcast Advertising of Restricted Devices 01/26/2004 08/09/2010
Guideline on Validation of the Limulus Amebocyte Lysate Test 12/01/1987 06/17/2011
Guideline for Validation of Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices 12/01/1987 07/08/2011
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review 09/01/2009 09/21/2011
Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling 09/12/2006 02/21/2012
In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling 11/24/1999 02/21/2012
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro 04/07/1997 02/21/2012
Cholestyramine Powder In Vitro Bioequivalence 01/15/1993 03/01/2012
Consumer-Directed Broadcast Advertising   08/09/1999 09/08/2012
Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment 06/22/2010 06/27/2012
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients 04/17/1998 08/07/2013
Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment 11/07/2003 08/07/2013
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 05/15/2001 08/07/2013
Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning on January 1, 2000 12/22/1999 08/07/2013
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products 02/20/1997 08/07/2013
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Lyme Disease—Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment 07/22/1998 08/07/2013
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
Developing Antimicrobial Drugs - General Considerations for Clinical Trials 07/22/1998 08/07/2013
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment 07/22/1998 08/07/2013
Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's 02/22/2001 08/07/2013
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems 07/25/2002 08/07/2013
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003-Questions and Answers
 
11/19/2004 08/07/2013
Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications 10/26/2000 08/07/2013
Submission of Patent Information for Certain Old Antibiotics 12/03/2008 08/07/2013
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act 10/01/1999 08/07/2013
Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals 12/19/2000 10/28/2013
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act 11/23/1998 09/22/2008
Providing Electronic Submissions in Electronic Format - ANDAs 06/07/2002 06/11/2008
Providing Electronic Submissions in Electronic Format - NDAs 01/28/1999 06/11/2008
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs 08/28/2003 06/11/2008
Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing 12/01/2005 06/05/2014
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis 06/14/2000 04/07/2015
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications 10/26/2000 04/07/2015
Accelerated Approval Products —Submission of Promotional Materials 03/26/1999 05/06/2015
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling 01/01/2001 05/06/2015
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information  09/05/2003 05/06/2015
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage  02/21/2012 05/06/2015
Providing Regulatory Submissions in Electronic Format - General Considerations  10/01/2003 05/06/2015
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches 12/16/2008 05/28/2015
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements 02/09/2015 08/06/2015
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis 06/07/2007 10/13/2015
Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination 03/09/2004 03/05/2016
Exercise Induced Bronchospasms (EIB) Development of Drugs 02/20/2002 05/10/2016
Classifying Resubmissions in Response to Action Letters 05/14/1998 05/27/2016
Photosafety Testing 05/07/2003 05/27/2016
Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act 12/04/2013 06/30/2016
Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling 01/12/1998 10/21/2016
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals 06/12/2015 11/18/2016
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Final 03/18/2002 09/22/2017
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Revision 1 01/27/2004 09/22/2017
M4: Granularity Annex: Final 10/01/2005 10/04/2017
Drug Safety Information – FDA’s Communication to the Public -Draft 03/08/2012 12/04/2017
Drug Safety Information – FDA’s Communication to the Public - Final 03/02/2007 12/04/2017
Formal Meetings Between the FDA and Sponsors or Applicants - Final 05/19/2009 12/27/2017
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products- Draft 03/10/2015 12/27/2017
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices 07/02/2009 12/13/2017
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft) 05/19/2016 03/26/2018
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment 11/01/2006 04/19/2018
Pediatric Oncology Studies In Response to a Written Request 06/21/2000 04/30/2018
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants 11/17/2015 06/04/2018
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommended Prescribing Information for Health Care Providers and Patient Labeling 11/16/2005 06/07/2018
Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry 09/21/2017 06/21/2018
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis 07/15/1999 08/22/2018