21 USC 355
§ 355 - New drugs
- § 355 - New drugs
- CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V— DRUGS AND DEVICES
- Notes
- Delayed Applicability of Amendment
- Editorial Notes
- References in Text
- Codification
- Amendments
- Statutory Notes and Related Subsidiaries
- Effective Date of 2026 Amendment
- Effective Date of 2025 Amendment
- Effective Date of 2022 Amendment
- Effective Date of 2021 Amendment
- Effective Date of 2012 Amendment
- Effective Date of 2007 Amendment
- Effective Date of 2003 Amendments
- Effective Date of 1999 Amendment
- Effective Date of 1997 Amendment
- Effective Date of 1984 Amendment
- Effective Date of 1972 Amendment
- Effective Date of 1962 Amendment
- Construction of Amendment by Pub. L. 110–85
- Construction of Amendments by Pub. L. 102–282
- Guidance
- Extending Expiration Dates for Certain Drugs
- Antifungal Research and Development
- Guidance on Diversity Action Plans for Clinical Studies
- Annual Summary Report on Progress To Increase Diversity in Clinical Studies
- Facilitating the Use of Real World Evidence
- Clarifying FDA Regulation of Non-Addictive Pain Products
- Guidance Regarding Reduction in Drug Effectiveness
- Annual Report on Inspections
- Report on Patient Experience Drug Development
- Novel Clinical Trial Designs
- Variations From CGMP Streamlined Approach
- FDA Opioid Action Plan
- Guidance on Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
- Guidance on Pathogen-Focused Antibacterial Drug Development
- Guidance on Abuse-Deterrent Products
- Extension of Period for First Applicant To Obtain Tentative Approval Without Forfeiting 180-Day-Exclusivity Period
- Effect of Amendments by Pub. L. 110–85 on Veterinary Medicine
- Effect of Amendment by Pub. L. 108–173 on Abbreviated New Drug Applications
- Federal Trade Commission Review
- Report on Patient Access to New Therapeutic Agents for Pediatric Cancer
- Data Requirements for Drugs and Biologics
- Requirements for Review of Approval Procedures and Current Good Manufacturing Practices for Positron Emission Technology
- Requirements for Radiopharmaceuticals
- Special Rule
- Transition
- Termination of Advisory Panels
- Appeals Taken Prior to October 10, 1962
- Executive Documents
- Transfer of Functions
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