Regulatory References | Drugs

Supply Chain Drug Supply Chain Search for Pharmaceutical Quality Documents Pharmaceutical Quality and Manufacturing Multiple Endpoints Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Ethical Considerations for Clinical Investigations Involving Children -Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Neonatal Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Patient-Focused Drug Development Clinical Outcome Assessments
Guidance
Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Food Effects Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Bioavailability Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Population Pharmacokinetics Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Pathology Peer Review Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Benefit-Risk Assessment for New Drug and Biologic Products Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Adjusting for Covariates Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval In Vitro Drug Interaction Studies Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Clinical Drug Interaction Studies Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Complex Innovative Trial Designs Guidance Snapshot Regulations, Laws, Guidances; Meetings, Engaging with FDA Maximal Usage Trials Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Targeted Therapies Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Multiple Endpoints Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Ethical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Neonatal Studies Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Patient-Focused Drug Development Clinical Outcome Assessments
Guidance Recap
Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Food Effects Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Bioavailability Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Population Pharmacokinetics Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Pathology Peer Review Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Adjusting for Covariates Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval In Vitro Drug Interaction Studies Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Clinical Drug Interaction Studies Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Complex Innovative Trial Designs Guidance Recap Podcast Transcript Regulations, Laws, Guidances; Meetings, Engaging with FDA Complex Generics News Generic Drugs, Abbreviated New Drug Applications Emerging Technology Program Pharmaceutical Quality and Manufacturing Oncology Regulatory Expertise and Early Guidance (OREEG) Clinical Trials, Drug Development and Approval, Investigational New Drug Development Application (IND), Meetings, Engaging with FDA OTC Monographs@FDA Over-the-Counter Drug Review Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act Over-the-Counter Drug Review Phonetic and Orthographic Computer Analysis (POCA) Program Drug Safety; Clinical Trials, Drug Development and Approval About CDER Small Business and Industry Assistance About FDA and CDER About FDA About FDA and CDER CDER Exclusivity Board About FDA and CDER CDER Ombudsman About FDA and CDER Doing Business With FDA About FDA and CDER Jobs at FDA About FDA and CDER Biosimilar Development, Review, and Approval Biologics, Biosimilars, Biologics License Application (BLA)  Biosimilar Product Information (FDA-Approved List of Biological Products) Biologics, Biosimilars, Biologics License Application (BLA)  Biosimilars Biologics, Biosimilars, Biologics License Application (BLA)  Biosimilars Action Plan Biologics, Biosimilars, Biologics License Application (BLA)  Bisoimilar Industry Information and Guidance Biologics, Biosimilars, Biologics License Application (BLA)  “Deemed to be a License Provision” of the BPCI Act Biologics, Biosimilars, Biologics License Application (BLA)  Frequently Asked Questions About Therapeutic Biological Products Biologics, Biosimilars, Biologics License Application (BLA)  Therapeutic Biologic Applications (BLA) Approval Information Biologics, Biosimilars, Biologics License Application (BLA)  Transfer of Therapeutic Products to CDER  Biologics, Biosimilars, Biologics License Application (BLA)  Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations Biologics, Biosimilars, Biologics License Application (BLA); Databases Biosimilar User Fee Amendments (BsUFA) Biologics, Biosimilars, Biologics License Application (BLA); User Fees Biomarker Qualification Program Clinical Trials, Drug Development and Approval Combination Products  Clinical Trials, Drug Development and Approval Clinical Trials and Human Subject Protection Clinical Trials, Drug Development and Approval Development & Approval Process Clinical Trials, Drug Development and Approval Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers Clinical Trials, Drug Development and Approval Drug Development Process Clinical Trials, Drug Development and Approval The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective Clinical Trials, Drug Development and Approval Economic Assistance and Incentives for Drug Development Clinical Trials, Drug Development and Approval Coronavirus (COVID-19) Clinical Trials, Drug Development and Approval COVID MyStudies Application (App) Clinical Trials, Drug Development and Approval Frequently Asked Questions on Patents and Exclusivity Clinical Trials, Drug Development and Approval Real-World Evidence Clinical Trials, Drug Development and Approval Compliance Actions and Activities Compliance, Inspections, Enforcement Inspections, Compliance, Enforcement, and Criminal Investigations Compliance, Inspections, Enforcement Unapproved Drugs Compliance, Inspections, Enforcement Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Compliance, Inspections, Enforcement Compounding and the FDA: Questions and Answers Compounding Compounding Risk Alerts Compounding Compounding: Inspections, Recalls, and other Actions Compounding Human Drug Compounding Compounding Acronyms and Abbreviations Search Databases Drug Approvals and Databases Databases Drugs@FDA Databases FDALabel Databases Inactive Ingredient Database Databases National Drug Code Directory Databases Drug Shortages Databases Search List of Extended Use Dates to Assist with Drug Shortages Databases Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Databases; Generic Drugs, Abbreviated New Drug Application (ANDA) Drug Master File webpage Drug Master Files Drug Master Files: Guidelines Drug Master Files Type II DMFs for Active Pharmaceutical Ingredients Drug Master Files Types of Drug Master Files (DMFs) Drug Master Files Drug Recalls Drug Safety, Recalls Drug Safety Communications Drug Safety, Recalls FDA Adverse Event Reporting System (FAERS) Public Dashboard Drug Safety, Recalls Medwatch Drug Safety, Recalls Preventable Adverse Drug Reactions: A Focus on Drug Interactions Drug Safety, Recalls Risk Evaluation and Mitigation Strategies (REMS) Drug Safety, Recalls Drug Safety Labeling Changes Drug Safety, Recalls; Labeling FDA Adverse Event Reporting System (FAERS) Electronic Submissions Drug Safety, Recalls; Submissions, Forms, Contacts Medwatch Reporting for Industry Drug Safety, Recalls; Submissions, Forms, Contacts Drug Safety and Availability Drug Safety; Databases Drug Supply Chain Integrity Drug Supply Chain Drug Supply Chain Security Act Drug Supply Chain Verify Wholesale Drug Distributor Licenses Drug Supply Chain Abbreviated New Drug Application (ANDA) Generic Drugs, Abbreviated New Drug Application (ANDA) Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry Generic Drugs, Abbreviated New Drug Application (ANDA) Dissolution Methods Database Generic Drugs, Abbreviated New Drug Application (ANDA) First Generic Drug Approvals Generic Drugs, Abbreviated New Drug Application (ANDA) Generic Drug Research-Related Guidances and Reports Generic Drugs, Abbreviated New Drug Application (ANDA) Generic Drugs: Information for Industry Generic Drugs, Abbreviated New Drug Application (ANDA) Guidance Documents for Generic Drugs (search Generics under topic) Generic Drugs, Abbreviated New Drug Application (ANDA) Guidance for Industry: ANDA Submission – Content and Format of ANDAs Generic Drugs, Abbreviated New Drug Application (ANDA) Orange Book Preface Generic Drugs, Abbreviated New Drug Application (ANDA) Patent Certifications and Suitability Petitions Generic Drugs, Abbreviated New Drug Application (ANDA) Product-Specific Guidances for Generic Drug Development Generic Drugs, Abbreviated New Drug Application (ANDA) Referencing Approved Drug Products in ANDA Submissions Guidance for Industry Generic Drugs, Abbreviated New Drug Application (ANDA) Self-Identification of Generic Drug Facilities, Sites and Organizations Generic Drugs, Abbreviated New Drug Application (ANDA) Pre-ANDA Program Generic Drugs, Abbreviated New Drug Application (ANDA); Meetings, Engaging with FDA FDA List of Authorized Generic Drugs Generic Drugs, Abbreviated New Drug Application (ANDA); New Drug Review, New Drug Application (NDA) ANDA Forms and Submissions Requirements Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts Controlled Correspondence Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts GDUFA web-based learning courses Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees Generic Drug User Fee Amendments (GDUFA) Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees Export certificates Import/Export, Regulatory Affairs, International Programs Import and Export of Human Drugs and Biologics Import/Export, Regulatory Affairs, International Programs Information for Exporters Import/Export, Regulatory Affairs, International Programs Office of Global Policy and Strategy Import/Export, Regulatory Affairs, International Programs Office of Regulatory Affairs (ORA) Directory   Import/Export, Regulatory Affairs, International Programs; Submissions, Forms, Contacts Expanded Access: Information for Industry Investigational New Drug Application (IND) Expedited Programs Investigational New Drug Application (IND) Exploratory INDs Investigational New Drug Application (IND) IND Exemptions Investigational New Drug Application (IND) Investigational New Drug (IND) Application Investigational New Drug Application (IND) Investigator-Initiated INDs and IND submission procedures Investigational New Drug Application (IND) Pregnancy and Lactation Labeling (Drugs) Final Rule Labeling FDA’s Labeling Resources for Human Prescription Drugs Labeling Table of Pharmacogenomic Biomarkers in Drug Labeling Labeling Medication Guides Labeling; Databases Advisory Committees (human drugs) Meetings, Engaging with FDA Best Practices for Communication Between IND Sponsors and FDA During Drug Development Meetings, Engaging with FDA Engaging with FDA during New Drug Development CDERLearn Course Meetings, Engaging with FDA News & Events for Human Drugs Meetings, Engaging with FDA; About FDA and CDER Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry Meetings, Engaging with FDA; Generic Drugs, Abbreviated New Drug Application (ANDA) Pre-IND Meeting FAQs     Meetings, Engaging with FDA; Investigational New Drug Application (IND) Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry Meetings, Engaging with FDA;
Biologics, Biosimilars, Biologics License Application (BLA)   Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products    Meetings, Engaging with FDA;
Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA) New Drug Application (NDA) Resources New Drug Review, New Drug Application (NDA) Pre-IND Consultation Program New Drug Review, New Drug Application (NDA) Requesting a Pre-Assigned Application number New Drug Review, New Drug Application (NDA) Coronavirus Treatment Acceleration Program (CTAP) New Drug Review, New Drug Application (NDA); Clinical Trials, Drug Development and Approval Applications Covered by Section 505(b)2) Guidance for Industry New Drug Review, New Drug Application (NDA); Investigational New Drug Application (IND) Prescription Drug User Fee Amendments (PDUFA) New Drug Review, New Drug Application (NDA); User Fees User Fee Waivers, Reduction, and Refunds for Drug and Biological Products – Guidance for Industry New Drug Review, New Drug Application (NDA); User Fees Development and Regulation of OTC (Nonprescription) Drugs Over-the-Counter Drug Review Drug applications for OTC drugs Over-the-Counter Drug Review OTC Monographs and Rulemaking Over-the-Counter Drug Review Over-the-Counter (OTC) Drug Monograph Process Over-the-Counter Drug Review Over-the-Counter Monograph User Fee Program (OMUFA) Over-the-Counter Drug Review; User Fees BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment Pharmaceutical Quality and Manufacturing Current Good Manufacturing Practice (CGMP) Regulations Pharmaceutical Quality and Manufacturing Developing and Manufacturing Drugs Including Biologics Pharmaceutical Quality and Manufacturing Drug Quality Sampling and Testing Programs Pharmaceutical Quality and Manufacturing Expiration Dates – Questions and Answers Pharmaceutical Quality and Manufacturing Facts About CGMPs Pharmaceutical Quality and Manufacturing Pharmaceutical Quality Resources  Pharmaceutical Quality and Manufacturing Quality Metrics for Drug Manufacturing Pharmaceutical Quality and Manufacturing Questions and Answers on CGMPs Pharmaceutical Quality and Manufacturing Questions and Answers on Current Good Manufacturing Practices—Control of Components and Drug Product Containers and Closures Pharmaceutical Quality and Manufacturing Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls Pharmaceutical Quality and Manufacturing Report a Product Quality Issue Pharmaceutical Quality and Manufacturing Current Good Manufacturing Practice (CGMP) Regulations Pharmaceutical Quality and Manufacturing; Regulations, Laws, Guidances Office of Prescription Drug Promotion (OPDP) Post-Marketing Activities and Promotion Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) Post-Marketing Activities and Promotion Postmarket Drug Safety Information for Patients and Providers Post-Marketing Activities and Promotion; Drug Safety Postmarketing Surveillance Programs Post-Marketing Activities and Promotion; Drug Safety Developing Products for Rare Diseases and Conditions Rare Diseases and Orphan Drugs Frequently Asked Questions (FAQ) About Designating an Orphan Product Rare Diseases and Orphan Drugs Search Orphan Drug Designations and Approvals Rare Diseases and Orphan Drugs CDER Direct: Electronic Submissions Portal Registration and Listing Electronic Drug Registration and Listing Instructions Registration and Listing Drug Establishments Current Registration Site (DECRS Database) Registration and Listing; Databases Registered Outsourcing Facilities (Compounding) Registration and Listing; Databases Code of Federal Regulations, Title 21 Regulations, Laws, Guidances Federal Food Drug & Cosmetic Act Regulations, Laws, Guidances Laws, Regulations and Guidances Regulations, Laws, Guidances Search for FDA Guidance Documents Regulations, Laws, Guidances CDER Reports & Budget Reports Division of Applied Regulatory Science Annual Reports Reports Drug and Biologic Approval and IND Activity Reports Reports Fast Track Approvals Reports GDUFA Science and Research Reports Reports IND Application Reporting: Safety Reports Reports NDA and BLA Approvals Reports NDA and BLA Calendar Year Approvals Reports Office of Clinical Pharmacology Annual Reports Reports Office of Generic Drugs Annual Reports Reports Office of New Drugs Annual Reports Reports Office of Pharmaceutical Quality Annual Reports Reports CDER Data Standards Program Submissions, Forms, Contacts CDER Direct NextGen Collaboration Portal Submissions, Forms, Contacts CDER Direct NextGen Collaboration Portal FAQs Submissions, Forms, Contacts Electronic Regulatory Submission and Review Submissions, Forms, Contacts FDA Forms Submissions, Forms, Contacts Forms and Submission Requirements Submissions, Forms, Contacts Office of New Drugs Contacts Submissions, Forms, Contacts Reorganization of the Office of New Drugs Submissions, Forms, Contacts Addresses for regulatory submissions Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) Electronic Common Technical Document (eCTD) Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) FDA IND, NDA, ANDA, or Drug Master File Binders Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA); Drug Master Files CDER SBIA Learn: Respository of Training Resources and Recordings Training Resources CDERLearn Training and Education Training Resources Stay Informed with FDA Interactive Media Training Resources Video and Transcript: FDA/CDER’€™s Small Business and Industry Assistance (SBIA) Training Resources FDA User Fee Programs User Fees

Source