Drugs

Withdrawn Guidances (Drugs)

Title Date Issued
(year-month-day)
Date Withdrawn
(year-month-day)
In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies 1997-12-30 1999-06-10
 Attachment D – Application, Product, and Establishment Fees:  Common Issues and Their Resolution 1994-12-16 2017-11-08
New Drug Evaluation Guidance Document: Refusal to File 1993-07-12 2017-05-19
Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability 1999-02-26 2000-02-03
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment 2000-05-16 2010-07-28
Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records 2002-11-12 2003-02-04
Guideline for the Clinical Evaluation of Analgesic Drugs 1992-12-01 2003-08-05
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV 2002-06-14 2003-11-21
Clinical Evaluation of Antacid Drugs 1978-04-01 2004-07-20
Clinical Evaluation of Antidiarrheal Drugs 1977-09-01 2004-07-20
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs 1977-09-01 2004-07-20
Clinical Evaluation of Laxative Drugs 1978-04-01 2004-07-20
Clinical Evaluation of Radiopharmaceutical Drugs 1981-10-01 2004-07-20
FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer 1989-06-01 2004-07-20
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing 2003-12-30 2011-04-01
Preclinical Development of Antiviral Drugs 1990-11-01 2005-07-06
Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders 1992-09-04 2005-12-29
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence 2000-03-09 2005-08-12
Organization of an Abbreviated New Drug Application 1999-03-02 2005-11-18
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes:  Chemistry, Manufacturing, and Controls Information 2001-02-01 2006-06-01
Drug Product: Chemistry, Manufacturing, and Controls Information 2003-01-01 2006-06-01
Drug Substance: Chemistry, Manufacturing, and Controls Information 2004-01-01 2006-06-01
Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application 1987-02-01 2006-06-01
Stability Testing of Drug Substances and Drug Products 1998-06-01 2006-06-01
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides 1994-11-01 2006-06-01
Submitting Documentation for the Stability of Human Drugs and Biologics 1987-02-01 2006-06-01
Providing Electronic Submissions in Electronic Format - ANDAs 2002-06-27 2006-09-29
Providing Electronic Submissions in Electronic Format - NDAs 1999-01-28 2006-09-29
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs 2003-08-28 2006-09-29
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV 2004-07-01 2006-07-05
Clinical Evaluation of Weight-Control Drugs 1996-09-01 2007-02-15
Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children) 1988-04-01 2008-05-29
Labeling OTC Skin Protectant Drug Products 2003-06-04 2008-08-04
Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis 2004-02-11 2009-12-02
Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA 2003-10-06 2010-04-09
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA 2004-11-22 2010-04-09
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement 2003-06-17 2010-04-09
Clinical Evaluation of Lipid – Altering Agents 1998-08-14 2010-04-16
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) 2000-12-04 2010-08-09
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) 1998-06-01 2011-10-17
Consumer-Directed Broadcast Advertising of Restricted Devices 2004-01-26 2010-08-09
Guideline on Validation of the Limulus Amebocyte Lysate Test 1987-12-01 2011-06-17
Guideline for Validation of Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices 1987-12-01 2011-07-08
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review 2009-09-01 2011-09-21
Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling 2006-09-12 2012-02-21
In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling 1999-11-24 2012-02-21
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro 1997-04-07 2012-02-21
Cholestyramine Powder In Vitro Bioequivalence 1993-01-15 2012-03-01
Consumer-Directed Broadcast Advertising   1999-08-09 2012-09-08
Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment 2010-06-22 2012-06-27
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients 1998-04-17 2013-08-07
Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment 2003-11-07 2013-08-07
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution 2001-05-15 2013-08-07
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 1999-12-22 2013-08-07
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products 1997-02-20 2013-08-07
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Lyme Disease—Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment 1998-07-22 2013-08-07
Developing Antimicrobial Drugs - General Considerations for Clinical Trials 1998-07-22 2013-08-07
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment 1998-07-22 2013-08-07
Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's 2001-02-22 2013-08-07
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems 2002-07-25 2013-08-07
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
 
2004-11-19 2013-08-07
Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications 2000-10-26 2013-08-07
Submission of Patent Information for Certain Old Antibiotics 2008-12-03 2013-08-07
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act 1999-10-01 2013-08-07
Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals 2000-12-19 2013-10-28
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act 1998-11-23 2008-09-22
Providing Electronic Submissions in Electronic Format - ANDAs 2002-06-07 2008-06-11
Providing Electronic Submissions in Electronic Format - NDAs 1999-01-28 2008-06-11
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs 2003-08-28 2008-06-11
Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing 2005-12-01 2014-06-05
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis 2000-06-14 2015-04-07
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications 2000-10-26 2015-04-07
Accelerated Approval Products —Submission of Promotional Materials 1999-03-26 2015-05-06
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling 2001-01-01 2015-05-06
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information  2003-09-05 2015-05-06
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage  2012-02-21 2015-05-06
Providing Regulatory Submissions in Electronic Format - General Considerations  2003-10-01 2015-05-06
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches 2008-12-16 2015-05-28
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements 2015-02-09 2015-08-06
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis 2007-06-07 2015-10-13
Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination 2004-03-09 2016-03-05
Exercise Induced Bronchospasms (EIB) Development of Drugs 2002-02-20 2016-05-10
Classifying Resubmissions in Response to Action Letters 1998-05-14 2016-05-27
Photosafety Testing 2003-05-07 2016-05-27
Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act 2013-12-04 2016-06-30
Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling 1998-01-12 2016-10-21
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals 2015-06-12 2016-11-18
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Final 2002-03-18 2017-09-22
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Revision 1 2004-01-27 2017-09-22
M4: Granularity Annex: Final 2005-10-01 2017-10-04
Drug Safety Information – FDA’s Communication to the Public -Draft 2012-03-08 2017-12-04
Drug Safety Information – FDA’s Communication to the Public - Final 2007-03-02 2017-12-04
Formal Meetings Between the FDA and Sponsors or Applicants - Final 2009-05-19 2017-12-27
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products- Draft 2015-03-10 2017-12-27
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices 2009-07-02 2017-12-13
Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft) 2016-05-19 2018-03-26
Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment 2006-11 2018-04-19
Pediatric Oncology Studies In Response to a Written Request 2000-06-21 2018-04-30
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants 2015-11-17 2018-06-04
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 2005-11-16 2018-06-07
Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry 2017-9-21 2018-6-21
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis 1999-7-15 2018-8-22
Guidelines for the Clinical Evaluation of Antiepileptic Drugs (Adults and Children) 1981-01-01 2018-10-12

 

 

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