Federal (United States) · Statute compilation
Pub. L. 112-144 — Food and Drug Administration Safety and Innovation Act
131 sections
1 group
100 sections filed directly here
- Pub. L. 112-144, tit. I, sec. 101 (as amended)SHORT TITLE; FINDING.
- Pub. L. 112-144, tit. I, sec. 102 (as amended)DEFINITIONS.
- Pub. L. 112-144, tit. I, sec. 103 (as amended)AUTHORITY TO ASSESS AND USE DRUG FEES.
- Pub. L. 112-144, tit. I, sec. 104 (as amended)REAUTHORIZATION; REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. I, sec. 105 (as amended)SUNSET DATES.
- Pub. L. 112-144, tit. I, sec. 106 (as amended)EFFECTIVE DATE.
- Pub. L. 112-144, tit. I, sec. 107 (as amended)SAVINGS CLAUSE.
- Pub. L. 112-144, tit. II, sec. 201 (as amended)SHORT TITLE; FINDINGS.
- Pub. L. 112-144, tit. II, sec. 202 (as amended)DEFINITIONS.
- Pub. L. 112-144, tit. II, sec. 203 (as amended)AUTHORITY TO ASSESS AND USE DEVICE FEES.
- Pub. L. 112-144, tit. II, sec. 204 (as amended)REAUTHORIZATION; REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. II, sec. 205 (as amended)SAVINGS CLAUSE.
- Pub. L. 112-144, tit. II, sec. 206 (as amended)EFFECTIVE DATE.
- Pub. L. 112-144, tit. II, sec. 207 (as amended)SUNSET CLAUSE.
- Pub. L. 112-144, tit. II, sec. 208 (as amended)STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE APPLICATIONS.
- Pub. L. 112-144, tit. III, sec. 301 (as amended)SHORT TITLE.
- Pub. L. 112-144, tit. III, sec. 302 (as amended)AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
- Pub. L. 112-144, tit. III, sec. 303 (as amended)REAUTHORIZATION; REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. III, sec. 305 (as amended)EFFECTIVE DATE.
- Pub. L. 112-144, tit. III, sec. 306 (as amended)AMENDMENT WITH RESPECT TO MISBRANDING.
- Pub. L. 112-144, tit. III, sec. 307 (as amended)STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO HUMAN GENERIC DRUGS.
- Pub. L. 112-144, tit. III, sec. 308 (as amended)ADDITIONAL REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. IV, sec. 401 (as amended)SHORT TITLE; FINDING.
- Pub. L. 112-144, tit. IV, sec. 402 (as amended)FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.
- Pub. L. 112-144, tit. IV, sec. 403 (as amended)REAUTHORIZATION; REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. IV, sec. 405 (as amended)EFFECTIVE DATE.
- Pub. L. 112-144, tit. IV, sec. 406 (as amended)SAVINGS CLAUSE.
- Pub. L. 112-144, tit. IV, sec. 407 (as amended)CONFORMING AMENDMENT.
- Pub. L. 112-144, tit. IV, sec. 408 (as amended)ADDITIONAL REPORTING REQUIREMENTS.
- Pub. L. 112-144, tit. V, sec. 501 (as amended)PERMANENCE.
- Pub. L. 112-144, tit. V, sec. 502 (as amended)WRITTEN REQUESTS.
- Pub. L. 112-144, tit. V, sec. 503 (as amended)COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.
- Pub. L. 112-144, tit. V, sec. 504 (as amended)ACCESS TO DATA.
- Pub. L. 112-144, tit. V, sec. 505 (as amended)ENSURING THE COMPLETION OF PEDIATRIC STUDIES.
- Pub. L. 112-144, tit. V, sec. 506 (as amended)PEDIATRIC STUDY PLANS.
- Pub. L. 112-144, tit. V, sec. 507 (as amended)REAUTHORIZATIONS.
- Pub. L. 112-144, tit. V, sec. 508 (as amended)REPORT.
- Pub. L. 112-144, tit. V, sec. 509 (as amended)TECHNICAL AMENDMENTS.
- Pub. L. 112-144, tit. V, sec. 510 (as amended)PEDIATRIC RARE DISEASES.
- Pub. L. 112-144, tit. V, sec. 511 (as amended)STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.
- Pub. L. 112-144, tit. VI, sec. 601 (as amended)INVESTIGATIONAL DEVICE EXEMPTIONS.
- Pub. L. 112-144, tit. VI, sec. 602 (as amended)CLARIFICATION OF LEAST BURDENSOME STANDARD.
- Pub. L. 112-144, tit. VI, sec. 603 (as amended)AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.
- Pub. L. 112-144, tit. VI, sec. 604 (as amended)DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING.
- Pub. L. 112-144, tit. VI, sec. 605 (as amended)PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
- Pub. L. 112-144, tit. VI, sec. 606 (as amended)CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.
- Pub. L. 112-144, tit. VI, sec. 607 (as amended)MODIFICATION OF DE NOVO APPLICATION PROCESS.
- Pub. L. 112-144, tit. VI, sec. 608 (as amended)RECLASSIFICATION PROCEDURES.
- Pub. L. 112-144, tit. VI, sec. 609 (as amended)HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND LABELING SYMBOLS.
- Pub. L. 112-144, tit. VI, sec. 610 (as amended)PARTICIPATION IN INTERNATIONAL FORA.
- Pub. L. 112-144, tit. VI, sec. 611 (as amended)REAUTHORIZATION OF THIRD-PARTY REVIEW.
- Pub. L. 112-144, tit. VI, sec. 612 (as amended)REAUTHORIZATION OF THIRD-PARTY INSPECTION.
- Pub. L. 112-144, tit. VI, sec. 613 (as amended)HUMANITARIAN DEVICE EXEMPTIONS.
- Pub. L. 112-144, tit. VI, sec. 614 (as amended)UNIQUE DEVICE IDENTIFIER.
- Pub. L. 112-144, tit. VI, sec. 615 (as amended)SENTINEL.
- Pub. L. 112-144, tit. VI, sec. 616 (as amended)POSTMARKET SURVEILLANCE.
- Pub. L. 112-144, tit. VI, sec. 617 (as amended)CUSTOM DEVICES.
- Pub. L. 112-144, tit. VI, sec. 618 (as amended)HEALTH INFORMATION TECHNOLOGY.
- Pub. L. 112-144, tit. VI, sec. 619 (as amended)GOOD GUIDANCE PRACTICES RELATING TO DEVICES.
- Pub. L. 112-144, tit. VI, sec. 620 (as amended)PEDIATRIC DEVICE CONSORTIA.
- Pub. L. 112-144, tit. VII, sec. 701 (as amended)REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.
- Pub. L. 112-144, tit. VII, sec. 702 (as amended)REGISTRATION OF FOREIGN ESTABLISHMENTS.
- Pub. L. 112-144, tit. VII, sec. 703 (as amended)IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT LISTING.
- Pub. L. 112-144, tit. VII, sec. 704 (as amended)ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
- Pub. L. 112-144, tit. VII, sec. 705 (as amended)RISK-BASED INSPECTION FREQUENCY.
- Pub. L. 112-144, tit. VII, sec. 706 (as amended)RECORDS FOR INSPECTION.
- Pub. L. 112-144, tit. VII, sec. 707 (as amended)PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR REFUSING INSPECTION.
- Pub. L. 112-144, tit. VII, sec. 708 (as amended)DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT.
- Pub. L. 112-144, tit. VII, sec. 709 (as amended)ADMINISTRATIVE DETENTION.
- Pub. L. 112-144, tit. VII, sec. 710 (as amended)EXCHANGE OF INFORMATION.
- Pub. L. 112-144, tit. VII, sec. 711 (as amended)ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.
- Pub. L. 112-144, tit. VII, sec. 712 (as amended)RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
- Pub. L. 112-144, tit. VII, sec. 713 (as amended)STANDARDS FOR ADMISSION OF IMPORTED DRUGS.
- Pub. L. 112-144, tit. VII, sec. 714 (as amended)REGISTRATION OF COMMERCIAL IMPORTERS.
- Pub. L. 112-144, tit. VII, sec. 715 (as amended)NOTIFICATION.
- Pub. L. 112-144, tit. VII, sec. 716 (as amended)PROTECTION AGAINST INTENTIONAL ADULTERATION.
- Pub. L. 112-144, tit. VII, sec. 717 (as amended)PENALTIES FOR COUNTERFEITING DRUGS.
- Pub. L. 112-144, tit. VII, sec. 718 (as amended)EXTRATERRITORIAL JURISDICTION.
- Pub. L. 112-144, tit. VIII, sec. 801 (as amended)EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
- Pub. L. 112-144, tit. VIII, sec. 802 (as amended)PRIORITY REVIEW.
- Pub. L. 112-144, tit. VIII, sec. 803 (as amended)FAST TRACK PRODUCT.
- Pub. L. 112-144, tit. VIII, sec. 804 (as amended)CLINICAL TRIALS.
- Pub. L. 112-144, tit. VIII, sec. 805 (as amended)REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT INCENTIVES IN 5 YEARS.
- Pub. L. 112-144, tit. VIII, sec. 806 (as amended)GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG DEVELOPMENT.
- Pub. L. 112-144, tit. IX, sec. 901 (as amended)ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL TREATMENTS.
- Pub. L. 112-144, tit. IX, sec. 902 (as amended)BREAKTHROUGH THERAPIES.
- Pub. L. 112-144, tit. IX, sec. 903 (as amended)CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.
- Pub. L. 112-144, tit. IX, sec. 904 (as amended)ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER LABELS BY VISUALLY IMPAIRED AND BLIND CONSUMERS.
- Pub. L. 112-144, tit. IX, sec. 905 (as amended)RISK-BENEFIT FRAMEWORK.
- Pub. L. 112-144, tit. IX, sec. 906 (as amended)GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.
- Pub. L. 112-144, tit. IX, sec. 907 (as amended)REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES.
- Pub. L. 112-144, tit. IX, sec. 908 (as amended)RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE PROGRAM.
- Pub. L. 112-144, tit. X, sec. 1001 (as amended)DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-SAVING DRUGS.
- Pub. L. 112-144, tit. X, sec. 1002 (as amended)ANNUAL REPORTING ON DRUG SHORTAGES.
- Pub. L. 112-144, tit. X, sec. 1003 (as amended)COORDINATION; TASK FORCE AND STRATEGIC PLAN.
- Pub. L. 112-144, tit. X, sec. 1004 (as amended)DRUG SHORTAGE LIST.
- Pub. L. 112-144, tit. X, sec. 1005 (as amended)QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.
- Pub. L. 112-144, tit. X, sec. 1006 (as amended)ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.
- Pub. L. 112-144, tit. X, sec. 1007 (as amended)HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
- Pub. L. 112-144, tit. X, sec. 1008 (as amended)STUDY ON DRUG SHORTAGES.