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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
Newly Added Guidance Documents 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
 
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