Withdrawn and Expired Guidances

Certification Process of Designated Medical Gases11/25/201512/18/2025Cancer Drug and Biological Products - Clinical Data in Marketing Applications10/12/200109/17/2025Oncologic Drug Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancers04/19/198809/17/2025FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer01/29/199109/17/2025FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products12/01/199809/17/2025Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry01/23/202011/05/2024In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry01/23/202011/05/2024Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning12/19/20122/16/2018CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and ANDAs09/21/201111/25/2020Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals03/22/202011/07/2023Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers05/17/202111/07/2023Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry04/09/202011/07/2023Marketed Unapproved Drugs -- Compliance Policy Guide04/09/202011/03/2023Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry03/04/202006/02/2023Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic*02/24/202205/11/2023Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers04/21/202105/11/2023Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency01/15/202105/11/2023Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry12/21/202005/11/2023Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency*09/10/202005/11/2023Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing*06/19/202005/11/2023Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency06/17/202005/11/2023Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers05/27/202005/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency04/06/202005/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry04/20/202005/11/2023Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency04/10/202005/11/2023Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency04/22/202005/11/2023Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency*06/08/202005/11/2023Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry03/04/202006/02/2023Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic*02/24/202205/11/2023Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers04/21/202105/11/2023Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency01/15/202105/11/2023Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry12/21/202005/11/2023Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency*09/10/202005/11/2023Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing*06/19/202005/11/2023Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency06/17/202005/11/2023Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers05/27/202005/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency04/06/202005/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry04/20/202005/11/2023Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency04/10/202005/11/2023Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency04/22/202005/11/2023Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency*06/08/2020Classifying Significant Postmarketing drug safety issues3/01/20124/20/2020Immunotoxicology Evaluation of Investigational New Drugs11/01/20022/19/2020Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes12/1/20083/9/2020Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention3/1/20083/9/2020Target Product Profile -- A Strategic Development Process Tool3/30/200712/13/2019Qualification Process for Drug Development Tools1/6/201412/13/2019Acceptance of Foreign Clinical Studies3/01/200112/06/2019CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed3/01/199510/24/2019Analgesic Indications: Developing Drugs and Biological Products2/14/201408/23/2019Guidelines for the Clinical Evaluation of Hypnotic Drugs9/01/199708/23/2019Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information12/29/201607/22/2019Analgesic Indications: Developing Drug and Biological Products02/05/201406/20/2019Establishing Pregnancy Exposure Registries08/01/200205/08/2019In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies12/30/199706/10/1999Attachment D – Application, Product, and Establishment Fees: Common Issues and Their Resolution12/16/199411/08/2017New Drug Evaluation Guidance Document: Refusal to File07/12/199305/19/2017Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability02/26/199902/03/2000Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment05/16/200007/28/2010Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records11/12/200202/04/2003Guideline for the Clinical Evaluation of Analgesic Drugs12/01/199208/05/2003Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV06/14/200211/21/2003Clinical Evaluation of Antacid Drugs04/01/197807/20/2004Clinical Evaluation of Antidiarrheal Drugs09/01/197707/20/2004Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs09/01/197707/20/2004Clinical Evaluation of Laxative Drugs04/01/197807/20/2004Clinical Evaluation of Radiopharmaceutical Drugs10/01/198107/20/2004FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer06/01/198907/20/2004Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing12/30/200304/01/2011Preclinical Development of Antiviral Drugs11/01/199007/06/2005Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders09/04/199212/29/2005Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence03/09/200008/12/2005Organization of an Abbreviated New Drug Application03/02/199911/18/2005BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Information02/01/200106/01/2006Drug Product: Chemistry, Manufacturing, and Controls Information01/01/200306/01/2006Drug Substance: Chemistry, Manufacturing, and Controls Information01/01/200406/01/2006Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application02/01/198706/01/2006Stability Testing of Drug Substances and Drug Products06/01/199806/01/2006Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides11/01/199406/01/2006Submitting Documentation for the Stability of Human Drugs and Biologics02/01/198706/01/2006Providing Electronic Submissions in Electronic Format - ANDAs06/27/200209/29/2006Providing Electronic Submissions in Electronic Format - NDAs01/28/199909/29/2006Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs08/28/200309/29/2006Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV07/01/200407/05/2006Clinical Evaluation of Weight-Control Drugs09/01/199602/15/2007Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children)04/01/198805/29/2008Labeling OTC Skin Protectant Drug Products06/04/200308/04/2008Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis02/11/200412/02/2009Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA10/06/200304/09/2010Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA11/22/200404/09/2010Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement06/17/200304/09/2010Clinical Evaluation of Lipid – Altering Agents08/14/199804/16/2010Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))12/04/200008/09/2010Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)06/01/199810/17/2011Consumer-Directed Broadcast Advertising of Restricted Devices01/26/200408/09/2010Guideline on Validation of the Limulus Amebocyte Lysate Test12/01/198706/17/2011Guideline for Validation of Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices12/01/198707/08/2011Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review09/01/200909/21/2011Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling09/12/200602/21/2012In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling11/24/199902/21/2012Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro04/07/199702/21/2012Cholestyramine Powder In Vitro Bioequivalence01/15/199303/01/2012Consumer-Directed Broadcast Advertising Questions and Answers08/09/199909/08/2012Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment06/22/201006/27/2012Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients04/17/199808/07/2013Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment11/07/200308/07/2013Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution05/15/200108/07/2013Disclosing 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, 200012/22/199908/07/2013Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products02/20/199708/07/2013Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Lyme Disease—Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment07/22/199808/07/2013Developing Antimicrobial Drugs - General Considerations for Clinical Trials07/22/199808/07/2013Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment07/22/199808/07/2013Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's02/22/200108/07/2013Inhalation Drug Products Packaged in Semipermeable Container Closure Systems07/25/200208/07/2013Listed 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 11/19/200408/07/2013Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications10/26/200008/07/2013Submission of Patent Information for Certain Old Antibiotics12/03/200808/07/2013Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act10/01/199908/07/2013Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals12/19/200010/28/2013Providing Electronic Submissions in Electronic Format - ANDAs06/07/200206/11/2008Providing Electronic Submissions in Electronic Format - NDAs01/28/199906/11/2008Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs08/28/200306/11/2008Accelerated Approval Products —Submission of Promotional Materials03/26/199905/06/2015Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling01/01/200105/06/2015Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information 09/05/200305/06/2015Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage 02/21/201205/06/2015Providing Regulatory Submissions in Electronic Format - General Considerations 10/01/200305/06/2015Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches12/16/200805/28/2015Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements02/09/201508/06/2015Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis06/07/200710/13/2015Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination03/09/200403/05/2016Exercise Induced Bronchospasms (EIB) Development of Drugs02/20/200205/10/2016Classifying Resubmissions in Response to Action Letters05/14/199805/27/2016Photosafety Testing05/07/200305/27/2016Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act12/04/201306/30/2016Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling01/12/199810/21/2016Assessment of Male-Mediated Developmental Risk for Pharmaceuticals06/12/201511/18/2016Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Final03/18/200209/22/2017Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Revision 101/27/200409/22/2017M4: Granularity Annex: Final10/01/200510/04/2017Drug Safety Information – FDA’s Communication to the Public -Draft03/08/201212/04/2017Drug Safety Information – FDA’s Communication to the Public - Final03/02/200712/04/2017Formal Meetings Between the FDA and Sponsors or Applicants - Final05/19/200912/27/2017Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products- Draft03/10/201512/27/2017Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices07/02/200912/13/2017Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft)05/19/201603/26/2018Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment11/01/200604/19/2018Pediatric Oncology Studies In Response to a Written Request06/21/200004/30/2018Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants11/17/201506/04/2018Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommended Prescribing Information for Health Care Providers and Patient Labeling11/16/200506/07/2018Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry09/21/201706/21/2018