Drugs

Withdrawn Guidances (Drugs)

TitleDate Issued
(year-month-day)
Date Withdrawn
(year-month-day)
In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies1997-12-301999-06-10
Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability1999-02-262000-02-03
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment2000-05-162010-07-28
Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records2002-11-122003-02-04
Guideline for the Clinical Evaluation of Analgesic Drugs1992-12-012003-08-05
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV2002-06-142003-11-21
Clinical Evaluation of Antacid Drugs1978-04-012004-07-20
Clinical Evaluation of Antidiarrheal Drugs1977-09-012004-07-20
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs1977-09-012004-07-20
Clinical Evaluation of Laxative Drugs1978-04-012004-07-20
Clinical Evaluation of Radiopharmaceutical Drugs1981-10-012004-07-20
FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer1989-06-012004-07-20
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing2003-12-302011-04-01
Preclinical Development of Antiviral Drugs1990-11-012005-07-06
Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders1992-09-042005-12-29
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence2000-03-092005-08-12
Organization of an Abbreviated New Drug Application1999-03-022005-11-18
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes:  Chemistry, Manufacturing, and Controls Information2001-02-012006-06-01
Drug Product: Chemistry, Manufacturing, and Controls Information2003-01-012006-06-01
Drug Substance: Chemistry, Manufacturing, and Controls Information2004-01-012006-06-01
Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application1987-02-012006-06-01
Stability Testing of Drug Substances and Drug Products1998-06-012006-06-01
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides1994-11-012006-06-01
Submitting Documentation for the Stability of Human Drugs and Biologics1987-02-012006-06-01
Providing Electronic Submissions in Electronic Format - ANDAs2002-06-272006-09-29
Providing Electronic Submissions in Electronic Format - NDAs1999-01-282006-09-29
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs2003-08-282006-09-29
Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV2004-07-012006-07-05
Clinical Evaluation of Weight-Control Drugs1996-09-012007-02-15
Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children)1988-04-012008-05-29
Labeling OTC Skin Protectant Drug Products2003-06-042008-08-04
Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis2004-02-112009-12-02
Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA2003-10-062010-04-09
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA2004-11-222010-04-09
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement2003-06-172010-04-09
Clinical Evaluation of Lipid – Altering Agents1998-08-142010-04-16
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))2000-12-042010-08-09
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)1998-06-012011-10-17
Consumer-Directed Broadcast Advertising of Restricted Devices2004-01-262010-08-09
Guideline on Validation of the Limulus Amebocyte Lysate Test1987-12-012011-06-17
Guideline for Validation of Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices1987-12-012011-07-08
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review2009-09-012011-09-21
Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling2006-09-122012-02-21
In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling1999-11-242012-02-21
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro1997-04-072012-02-21
Cholestyramine Powder In Vitro Bioequivalence1993-01-152012-03-01
Consumer-Directed Broadcast Advertising  1999-08-092012-09-08
Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment2010-06-222012-06-27
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients1998-04-172013-08-07
Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment2003-11-072013-08-07
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution2001-05-152013-08-07
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, 20001999-12-222013-08-07
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products1997-02-202013-08-07
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Lyme Disease—Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment1998-07-222013-08-07
Developing Antimicrobial Drugs - General Considerations for Clinical Trials1998-07-222013-08-07
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment1998-07-222013-08-07
Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's2001-02-222013-08-07
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems2002-07-252013-08-07
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
 
2004-11-192013-08-07
Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications2000-10-262013-08-07
Submission of Patent Information for Certain Old Antibiotics2008-12-032013-08-07
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act1999-10-012013-08-07
Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals2000-12-192013-10-28
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act1998-11-232008-09-22
Providing Electronic Submissions in Electronic Format - ANDAs2002-06-072008-06-11
Providing Electronic Submissions in Electronic Format - NDAs1999-01-282008-06-11
Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs2003-08-282008-06-11
Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing2005-12-012014-06-05
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis2000-06-142015-04-07
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications2000-10-262015-04-07
Accelerated Approval Products —Submission of Promotional Materials1999-03-262015-05-06
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling2001-01-012015-05-06
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information 2003-09-052015-05-06
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage 2012-02-212015-05-06
Providing Regulatory Submissions in Electronic Format - General Considerations 2003-10-012015-05-06
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches2008-12-162015-05-28
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements2015-02-092015-08-06
Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis2007-06-072015-10-13
Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination2004-03-092016-03-05
Exercise Induced Bronchospasms (EIB) Development of Drugs2002-02-202016-05-10
Classifying Resubmissions in Response to Action Letters1998-05-142016-05-27
Photosafety Testing2003-05-072016-05-27
Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act2013-12-042016-06-30
Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling1998-01-122016-10-21
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals2015-06-122016-11-18

 

 

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