Federal (United States) · Session law
Pub. L. 115-52 — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.
70 sections
70 sections
- Pub. L. 115-52, tit. I, sec. 101SHORT TITLE; FINDING.Enacted
- Pub. L. 115-52, tit. I, sec. 102AUTHORITY TO ASSESS AND USE DRUG FEES.Enacted
- Pub. L. 115-52, tit. I, sec. 103REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 115-52, tit. I, sec. 104SUNSET DATES.Enacted
- Pub. L. 115-52, tit. I, sec. 105EFFECTIVE DATE.Enacted
- Pub. L. 115-52, tit. I, sec. 106SAVINGS CLAUSE.Enacted
- Pub. L. 115-52, tit. II, sec. 201SHORT TITLE; FINDING.Enacted
- Pub. L. 115-52, tit. II, sec. 202DEFINITIONS.Enacted
- Pub. L. 115-52, tit. II, sec. 203AUTHORITY TO ASSESS AND USE DEVICE FEES.Enacted
- Pub. L. 115-52, tit. II, sec. 204REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 115-52, tit. II, sec. 205CONFORMITY ASSESSMENT PILOT PROGRAM.Enacted
- Pub. L. 115-52, tit. II, sec. 206REAUTHORIZATION OF REVIEW.Enacted
- Pub. L. 115-52, tit. II, sec. 207ELECTRONIC FORMAT FOR SUBMISSIONS.Enacted
- Pub. L. 115-52, tit. II, sec. 208SAVINGS CLAUSE.Enacted
- Pub. L. 115-52, tit. II, sec. 209EFFECTIVE DATE.Enacted
- Pub. L. 115-52, tit. II, sec. 210SUNSET DATES.Enacted
- Pub. L. 115-52, tit. III, sec. 301SHORT TITLE; FINDING.Enacted
- Pub. L. 115-52, tit. III, sec. 302DEFINITIONS.Enacted
- Pub. L. 115-52, tit. III, sec. 303AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.Enacted
- Pub. L. 115-52, tit. III, sec. 304REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 115-52, tit. III, sec. 305SUNSET DATES.Enacted
- Pub. L. 115-52, tit. III, sec. 306EFFECTIVE DATE.Enacted
- Pub. L. 115-52, tit. III, sec. 307SAVINGS CLAUSE.Enacted
- Pub. L. 115-52, tit. IV, sec. 401SHORT TITLE; FINDING.Enacted
- Pub. L. 115-52, tit. IV, sec. 402DEFINITIONS.Enacted
- Pub. L. 115-52, tit. IV, sec. 403AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.Enacted
- Pub. L. 115-52, tit. IV, sec. 404REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 115-52, tit. IV, sec. 405SUNSET DATES.Enacted
- Pub. L. 115-52, tit. IV, sec. 406EFFECTIVE DATE.Enacted
- Pub. L. 115-52, tit. IV, sec. 407SAVINGS CLAUSE.Enacted
- Pub. L. 115-52, tit. V, sec. 501BEST PHARMACEUTICALS FOR CHILDREN.Enacted
- Pub. L. 115-52, tit. V, sec. 502PEDIATRIC DEVICES.Enacted
- Pub. L. 115-52, tit. V, sec. 503EARLY MEETING ON PEDIATRIC STUDY PLAN.Enacted
- Pub. L. 115-52, tit. V, sec. 504DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC CANCERS.Enacted
- Pub. L. 115-52, tit. V, sec. 505ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.Enacted
- Pub. L. 115-52, tit. VI, sec. 601REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.Enacted
- Pub. L. 115-52, tit. VI, sec. 602REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.Enacted
- Pub. L. 115-52, tit. VI, sec. 603REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.Enacted
- Pub. L. 115-52, tit. VI, sec. 604PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.Enacted
- Pub. L. 115-52, tit. VI, sec. 605PATIENT EXPERIENCE DATA.Enacted
- Pub. L. 115-52, tit. VI, sec. 606COMMUNICATION PLANS.Enacted
- Pub. L. 115-52, tit. VI, sec. 607ORPHAN DRUGS.Enacted
- Pub. L. 115-52, tit. VI, sec. 608PEDIATRIC INFORMATION ADDED TO LABELING.Enacted
- Pub. L. 115-52, tit. VI, sec. 609SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.Enacted
- Pub. L. 115-52, tit. VI, sec. 610EXPANDED ACCESS.Enacted
- Pub. L. 115-52, tit. VI, sec. 611TROPICAL DISEASE PRODUCT APPLICATION.Enacted
- Pub. L. 115-52, tit. VII, sec. 701RISK-BASED INSPECTIONS FOR DEVICES.Enacted
- Pub. L. 115-52, tit. VII, sec. 702IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS.Enacted
- Pub. L. 115-52, tit. VII, sec. 703REAUTHORIZATION OF INSPECTION PROGRAM.Enacted
- Pub. L. 115-52, tit. VII, sec. 704CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.Enacted
- Pub. L. 115-52, tit. VII, sec. 705FACILITATING INTERNATIONAL HARMONIZATION.Enacted
- Pub. L. 115-52, tit. VII, sec. 706FOSTERING INNOVATION IN MEDICAL IMAGING.Enacted
- Pub. L. 115-52, tit. VII, sec. 707RISK-BASED CLASSIFICATION OF ACCESSORIES.Enacted
- Pub. L. 115-52, tit. VII, sec. 708DEVICE PILOT PROJECTS.Enacted
- Pub. L. 115-52, tit. VII, sec. 709REGULATION OF OVER-THE-COUNTER HEARING AIDS.Enacted
- Pub. L. 115-52, tit. VII, sec. 710REPORT ON SERVICING OF DEVICES.Enacted
- Pub. L. 115-52, tit. VIII, sec. 801PRIORITY REVIEW OF GENERIC DRUGS.Enacted
- Pub. L. 115-52, tit. VIII, sec. 802ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION.Enacted
- Pub. L. 115-52, tit. VIII, sec. 803COMPETITIVE GENERIC THERAPIES.Enacted
- Pub. L. 115-52, tit. VIII, sec. 804ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.Enacted
- Pub. L. 115-52, tit. VIII, sec. 805SUITABILITY PETITIONS.Enacted
- Pub. L. 115-52, tit. VIII, sec. 806INSPECTIONS.Enacted
- Pub. L. 115-52, tit. VIII, sec. 807REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS.Enacted
- Pub. L. 115-52, tit. VIII, sec. 808INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.Enacted
- Pub. L. 115-52, tit. VIII, sec. 809GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES.Enacted
- Pub. L. 115-52, tit. IX, sec. 901TECHNICAL CORRECTIONS.Enacted
- Pub. L. 115-52, tit. IX, sec. 902ANNUAL REPORT ON INSPECTIONS.Enacted
- Pub. L. 115-52, tit. IX, sec. 903STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING.Enacted
- Pub. L. 115-52, tit. IX, sec. 904ANALYSIS OF USE OF FUNDS.Enacted
- Pub. L. 115-52, tit. IX, sec. 905FACILITIES MANAGEMENT.Enacted