Pub. L. 115-52
Pub. L. 115-52 - FDA Reauthorization Act of 2017
- Pub. L. 115-52 - FDA Reauthorization Act of 2017
- 115th Congress
- SECTION 1. SHORT TITLE.
- SEC. 2. TABLE OF CONTENTS.
- SEC. 101. SHORT TITLE; FINDING.
- SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.
- SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
- SEC. 104. SUNSET DATES.
- SEC. 105. EFFECTIVE DATE.
- SEC. 106. SAVINGS CLAUSE.
- SEC. 201. SHORT TITLE; FINDING.
- SEC. 202. DEFINITIONS.
- SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
- SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
- SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
- SEC. 206. REAUTHORIZATION OF REVIEW.
- SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
- SEC. 208. SAVINGS CLAUSE.
- SEC. 209. EFFECTIVE DATE.
- SEC. 210. SUNSET DATES.
- SEC. 301. SHORT TITLE; FINDING.
- SEC. 302. DEFINITIONS.
- SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
- SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
- SEC. 305. SUNSET DATES.
- SEC. 306. EFFECTIVE DATE.
- SEC. 307. SAVINGS CLAUSE.
- SEC. 401. SHORT TITLE; FINDING.
- SEC. 402. DEFINITIONS.
- SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
- SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
- SEC. 405. SUNSET DATES.
- SEC. 406. EFFECTIVE DATE.
- SEC. 407. SAVINGS CLAUSE.
- SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.
- SEC. 502. PEDIATRIC DEVICES.
- SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.
- SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC CANCERS.
- SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.
- SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
- SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
- SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
- SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.
- SEC. 605. PATIENT EXPERIENCE DATA.
- SEC. 606. COMMUNICATION PLANS.
- SEC. 607. ORPHAN DRUGS.
- SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.
- SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.
- SEC. 610. EXPANDED ACCESS.
- SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.
- SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.
- SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS.
- SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.
- SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
- SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.
- SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.
- SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.
- SEC. 708. DEVICE PILOT PROJECTS.
- SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
- SEC. 710. REPORT ON SERVICING OF DEVICES.
- SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.
- SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION.
- SEC. 803. COMPETITIVE GENERIC THERAPIES.
- SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.
- SEC. 805. SUITABILITY PETITIONS.
- SEC. 806. INSPECTIONS.
- SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS.
- SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.
- SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES.
- SEC. 901. TECHNICAL CORRECTIONS.
- SEC. 902. ANNUAL REPORT ON INSPECTIONS.
- SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING.
- SEC. 904. ANALYSIS OF USE OF FUNDS.
- SEC. 905. FACILITIES MANAGEMENT.
- Legislative History
- LEGISLATIVE HISTORY—H.R. 2430 (S. 934):
- CONGRESSIONAL RECORD, Vol. 163 (2017):
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