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                Guidances | Drugs

Guidances | Drugs

                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot Home
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          Guidance, Compliance, & Regulatory Information
          Guidances | Drugs
          Withdrawn | Expired GuidancesGuidances | Drugs Withdrawn | Expired Guidances
  
  	
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			Date Issued
			Date Withdrawn
			Date ExpiredPolicy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals
			03/22/2020
			11/07/2023Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
			05/17/2021
			11/07/2023Policy 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 Industry
			04/09/2020
			11/07/2023Marketed Unapproved Drugs -- Compliance Policy Guide
			04/09/2020
			11/03/2023Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry
			03/04/2020
			06/02/2023Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic*
			02/24/2022
			05/11/2023Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers
			04/21/2021
			05/11/2023Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
			01/15/2021
			05/11/2023Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry
			12/21/2020
			05/11/2023Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency*
			09/10/2020
			05/11/2023Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing*
			06/19/2020
			05/11/2023Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
			06/17/2020
			05/11/2023Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers
			05/27/2020
			05/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
			04/06/2020
			05/11/2023Temporary 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 Industry
			04/20/2020
			05/11/2023Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency
			04/10/2020
			05/11/2023Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency
			04/22/2020
			05/11/2023Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency*
			06/08/2020
			05/11/2023Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry
			03/04/2020
			06/02/2023Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic*
			02/24/2022
			05/11/2023Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers
			04/21/2021
			05/11/2023Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
			01/15/2021
			05/11/2023Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry
			12/21/2020
			05/11/2023Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency*
			09/10/2020
			05/11/2023Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing*
			06/19/2020
			05/11/2023Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
			06/17/2020
			05/11/2023Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers
			05/27/2020
			05/11/2023Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
			04/06/2020
			05/11/2023Temporary 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 Industry
			04/20/2020
			05/11/2023Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency
			04/10/2020
			05/11/2023Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency
			04/22/2020
			05/11/2023Temporary 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 issues
			3/01/2012
			4/20/2020Immunotoxicology Evaluation of Investigational New Drugs
			11/01/2002
			2/19/2020Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
			12/1/2008
			3/9/2020Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention
			3/1/2008
			3/9/2020Target Product Profile -- A Strategic Development Process Tool
			3/30/2007
			12/13/2019Qualification Process for Drug Development Tools
			1/6/2014
			12/13/2019Acceptance of Foreign Clinical Studies
			3/01/2001
			12/06/2019CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed
			3/01/1995
			10/24/2019Analgesic Indications: Developing Drugs and Biological Products
			2/14/2014
			08/23/2019Guidelines for the Clinical Evaluation of Hypnotic Drugs
			9/01/1997
			08/23/2019Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information
			12/29/2016
			07/22/2019Analgesic Indications: Developing Drug and Biological Products
			02/05/2014
			06/20/2019Establishing Pregnancy Exposure Registries
			08/01/2002
			05/08/2019In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies
			12/30/1997
			06/10/1999Attachment D – Application, Product, and Establishment Fees:  Common Issues and Their Resolution
			12/16/1994
			11/08/2017New Drug Evaluation Guidance Document: Refusal to File
			07/12/1993
			05/19/2017Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability
			02/26/1999
			02/03/2000Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment
			05/16/2000
			07/28/2010Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
			11/12/2002
			02/04/2003Guideline for the Clinical Evaluation of Analgesic Drugs
			12/01/1992
			08/05/2003Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV
			06/14/2002
			11/21/2003Clinical Evaluation of Antacid Drugs
			04/01/1978
			07/20/2004Clinical Evaluation of Antidiarrheal Drugs
			09/01/1977
			07/20/2004Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs
			09/01/1977
			07/20/2004Clinical Evaluation of Laxative Drugs
			04/01/1978
			07/20/2004Clinical Evaluation of Radiopharmaceutical Drugs
			10/01/1981
			07/20/2004FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer
			06/01/1989
			07/20/2004Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing
			12/30/2003
			04/01/2011Preclinical Development of Antiviral Drugs
			11/01/1990
			07/06/2005Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders
			09/04/1992
			12/29/2005Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence
			03/09/2000
			08/12/2005Organization of an Abbreviated New Drug Application
			03/02/1999
			11/18/2005BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes:  Chemistry, Manufacturing, and Controls Information
			02/01/2001
			06/01/2006Drug Product: Chemistry, Manufacturing, and Controls Information
			01/01/2003
			06/01/2006Drug Substance: Chemistry, Manufacturing, and Controls Information
			01/01/2004
			06/01/2006Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
			02/01/1987
			06/01/2006Stability Testing of Drug Substances and Drug Products
			06/01/1998
			06/01/2006Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides
			11/01/1994
			06/01/2006Submitting Documentation for the Stability of Human Drugs and Biologics
			02/01/1987
			06/01/2006Providing Electronic Submissions in Electronic Format - ANDAs
			06/27/2002
			09/29/2006Providing Electronic Submissions in Electronic Format - NDAs
			01/28/1999
			09/29/2006Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs
			08/28/2003
			09/29/2006Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV
			07/01/2004
			07/05/2006Clinical Evaluation of Weight-Control Drugs
			09/01/1996
			02/15/2007Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children)
			04/01/1988
			05/29/2008Labeling OTC Skin Protectant Drug Products
			06/04/2003
			08/04/2008Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
			02/11/2004
			12/02/2009Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA
			10/06/2003
			04/09/2010Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA
			11/22/2004
			04/09/2010Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement
			06/17/2003
			04/09/2010Clinical Evaluation of Lipid – Altering Agents
			08/14/1998
			04/16/2010Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))
			12/04/2000
			08/09/2010Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)
			06/01/1998
			10/17/2011Consumer-Directed Broadcast Advertising of Restricted Devices
			01/26/2004
			08/09/2010Guideline on Validation of the Limulus Amebocyte Lysate Test
			12/01/1987
			06/17/2011Guideline 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
			07/08/2011Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review
			09/01/2009
			09/21/2011Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling
			09/12/2006
			02/21/2012In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling
			11/24/1999
			02/21/2012Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro
			04/07/1997
			02/21/2012Cholestyramine Powder In Vitro Bioequivalence
			01/15/1993
			03/01/2012Consumer-Directed Broadcast Advertising Questions and Answers
			08/09/1999
			09/08/2012Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment
			06/22/2010
			06/27/2012Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
			04/17/1998
			08/07/2013Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment
			11/07/2003
			08/07/2013Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
			05/15/2001
			08/07/2013Disclosing 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, 2000
			12/22/1999
			08/07/2013Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products
			02/20/1997
			08/07/2013Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Lyme Disease—Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment
			07/22/1998
			08/07/2013Developing Antimicrobial Drugs - General Considerations for Clinical Trials
			07/22/1998
			08/07/2013Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment
			07/22/1998
			08/07/2013Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's
			02/22/2001
			08/07/2013Inhalation Drug Products Packaged in Semipermeable Container Closure Systems
			07/25/2002
			08/07/2013Listed 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
			11/19/2004
			08/07/2013Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications
			10/26/2000
			08/07/2013Submission of Patent Information for Certain Old Antibiotics
			12/03/2008
			08/07/2013Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
			10/01/1999
			08/07/2013Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals
			12/19/2000
			10/28/2013Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act
			11/23/1998
			09/22/2008Providing Electronic Submissions in Electronic Format - ANDAs
			06/07/2002
			06/11/2008Providing Electronic Submissions in Electronic Format - NDAs
			01/28/1999
			06/11/2008Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs
			08/28/2003
			06/11/2008Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing
			12/01/2005
			06/05/2014Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis
			06/14/2000
			04/07/2015Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications
			10/26/2000
			04/07/2015Accelerated Approval Products —Submission of Promotional Materials
			03/26/1999
			05/06/2015Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling
			01/01/2001
			05/06/2015Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information
			09/05/2003
			05/06/2015Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage
			02/21/2012
			05/06/2015Providing Regulatory Submissions in Electronic Format - General Considerations
			10/01/2003
			05/06/2015Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
			12/16/2008
			05/28/2015Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements
			02/09/2015
			08/06/2015Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
			06/07/2007
			10/13/2015Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination
			03/09/2004
			03/05/2016Exercise Induced Bronchospasms (EIB) Development of Drugs
			02/20/2002
			05/10/2016Classifying Resubmissions in Response to Action Letters
			05/14/1998
			05/27/2016Photosafety Testing
			05/07/2003
			05/27/2016Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act
			12/04/2013
			06/30/2016Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling
			01/12/1998
			10/21/2016Assessment of Male-Mediated Developmental Risk for Pharmaceuticals
			06/12/2015
			11/18/2016Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Final
			03/18/2002
			09/22/2017Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Revision 1
			01/27/2004
			09/22/2017M4: Granularity Annex: Final
			10/01/2005
			10/04/2017Drug Safety Information – FDA’s Communication to the Public -Draft
			03/08/2012
			12/04/2017Drug Safety Information – FDA’s Communication to the Public - Final
			03/02/2007
			12/04/2017Formal Meetings Between the FDA and Sponsors or Applicants - Final
			05/19/2009
			12/27/2017Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products- Draft
			03/10/2015
			12/27/2017Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
			07/02/2009
			12/13/2017Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft)
			05/19/2016
			03/26/2018Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment
			11/01/2006
			04/19/2018Pediatric Oncology Studies In Response to a Written Request
			06/21/2000
			04/30/2018Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
			11/17/2015
			06/04/2018Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommended Prescribing Information for Health Care Providers and Patient Labeling
			11/16/2005
			06/07/2018Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry
			09/21/2017
			06/21/2018Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis
			07/15/1999
			08/22/2018

                                                                                  Content current as of:
      11/07/2023
              
              
Regulated Product(s)
		 DrugsGuidances | Drugs

          
                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot
 
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