Legalize59765 laws
59765 laws
- § 356–2. Accelerated approval Council
- § 357. Qualification of drug development tools
- § 358. Authority to designate official names
- § 359. Nonapplicability of subchapter to cosmetics
- § 360. Registration of producers of drugs or devices
- § 360a. Clinical trial guidance for antibiotic drugs
- § 360aa. Recommendations for investigations of drugs for rare diseases or conditions
- § 360b. New animal drugs
- § 360bb. Designation of drugs for rare diseases or conditions
- § 360bbb. Expanded access to unapproved therapies and diagnostics
- § 360bbb–0. Expanded access policy required for investigational drugs
- § 360bbb–0a. Investigational drugs for use by eligible patients
- § 360bbb–1. Dispute resolution
- § 360bbb–2. Classification of products
- § 360bbb–3. Authorization for medical products for use in emergencies
- § 360bbb–3a. Emergency use of medical products
- § 360bbb–3b. Products held for emergency use
- § 360bbb–3c. Expedited development and review of medical products for emergency uses
- § 360bbb–4. Countermeasure development, review, and technical assistance
- § 360bbb–4a. Priority review to encourage treatments for agents that present national security threats
- § 360bbb–4b. Medical countermeasure master files
- § 360bbb–5. Critical Path Public-Private Partnerships
- § 360bbb–5a. Emerging technology program
- § 360bbb–6. Risk communication
- § 360bbb–7. Notification
- § 384g. Restricting entrance of illicit drugs
- § 360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- § 360bbb–8a. Optimizing global clinical trials
- § 360bbb–8b. Use of clinical investigation data from outside the United States
- § 360bbb–8c. Patient participation in medical product discussion
- § 360bbb–8d. Notification, nondistribution, and recall of controlled substances
- § 360b–1. Priority zoonotic animal drugs
- § 360c. Classification of devices intended for human use
- § 360cc. Protection for drugs for rare diseases or conditions
- § 387. Definitions
- § 360ccc. Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
- § 360ccc–1. Index of legally marketed unapproved new animal drugs for minor species
- § 360ccc–2. Designated new animal drugs for minor use or minor species
- § 360c–1. Reporting
- § 360d. Performance standards
- § 360dd. Open protocols for investigations of drugs for rare diseases or conditions
- § 360ddd. Definitions
- § 360ddd–1. Regulation of medical gases
- § 360ddd–2. Inapplicability of drug fees to designated medical gases
- § 360e. Premarket approval
- § 360ee. Grants and contracts for development of drugs for rare diseases and conditions
- § 360eee. Definitions
- § 360eee–1. Requirements
- § 360eee–2. National standards for prescription drug wholesale distributors
- § 360eee–3. National standards for third-party logistics providers