Federal (United States) · Session law
Pub. L. 112-144 — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.
133 sections
1 group
102 sections filed directly here
- Pub. L. 112-144, tit. I, sec. 101SHORT TITLE; FINDING.Enacted
- Pub. L. 112-144, tit. I, sec. 102DEFINITIONS.Enacted
- Pub. L. 112-144, tit. I, sec. 103AUTHORITY TO ASSESS AND USE DRUG FEES.Enacted
- Pub. L. 112-144, tit. I, sec. 104REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. I, sec. 105SUNSET DATES.Enacted
- Pub. L. 112-144, tit. I, sec. 106EFFECTIVE DATE.Enacted
- Pub. L. 112-144, tit. I, sec. 107SAVINGS CLAUSE.Enacted
- Pub. L. 112-144, tit. II, sec. 201SHORT TITLE; FINDINGS.Enacted
- Pub. L. 112-144, tit. II, sec. 202DEFINITIONS.Enacted
- Pub. L. 112-144, tit. II, sec. 203AUTHORITY TO ASSESS AND USE DEVICE FEES.Enacted
- Pub. L. 112-144, tit. II, sec. 204REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. II, sec. 205SAVINGS CLAUSE.Enacted
- Pub. L. 112-144, tit. II, sec. 206EFFECTIVE DATE.Enacted
- Pub. L. 112-144, tit. II, sec. 207SUNSET CLAUSE.Enacted
- Pub. L. 112-144, tit. II, sec. 208STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE APPLICATIONS.Enacted
- Pub. L. 112-144, tit. III, sec. 301SHORT TITLE.Enacted
- Pub. L. 112-144, tit. III, sec. 302AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.Enacted
- Pub. L. 112-144, tit. III, sec. 303REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. III, sec. 304SUNSET DATES.Enacted
- Pub. L. 112-144, tit. III, sec. 305EFFECTIVE DATE.Enacted
- Pub. L. 112-144, tit. III, sec. 306AMENDMENT WITH RESPECT TO MISBRANDING.Enacted
- Pub. L. 112-144, tit. III, sec. 307STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES RELATED TO HUMAN GENERIC DRUGS.Enacted
- Pub. L. 112-144, tit. III, sec. 308ADDITIONAL REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. IV, sec. 401SHORT TITLE; FINDING.Enacted
- Pub. L. 112-144, tit. IV, sec. 402FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.Enacted
- Pub. L. 112-144, tit. IV, sec. 403REAUTHORIZATION; REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. IV, sec. 404SUNSET DATES.Enacted
- Pub. L. 112-144, tit. IV, sec. 405EFFECTIVE DATE.Enacted
- Pub. L. 112-144, tit. IV, sec. 406SAVINGS CLAUSE.Enacted
- Pub. L. 112-144, tit. IV, sec. 407CONFORMING AMENDMENT.Enacted
- Pub. L. 112-144, tit. IV, sec. 408ADDITIONAL REPORTING REQUIREMENTS.Enacted
- Pub. L. 112-144, tit. V, sec. 501PERMANENCE.Enacted
- Pub. L. 112-144, tit. V, sec. 502WRITTEN REQUESTS.Enacted
- Pub. L. 112-144, tit. V, sec. 503COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.Enacted
- Pub. L. 112-144, tit. V, sec. 504ACCESS TO DATA.Enacted
- Pub. L. 112-144, tit. V, sec. 505ENSURING THE COMPLETION OF PEDIATRIC STUDIES.Enacted
- Pub. L. 112-144, tit. V, sec. 506PEDIATRIC STUDY PLANS.Enacted
- Pub. L. 112-144, tit. V, sec. 507REAUTHORIZATIONS.Enacted
- Pub. L. 112-144, tit. V, sec. 508REPORT.Enacted
- Pub. L. 112-144, tit. V, sec. 509TECHNICAL AMENDMENTS.Enacted
- Pub. L. 112-144, tit. V, sec. 510PEDIATRIC RARE DISEASES.Enacted
- Pub. L. 112-144, tit. V, sec. 511STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.Enacted
- Pub. L. 112-144, tit. VI, sec. 601INVESTIGATIONAL DEVICE EXEMPTIONS.Enacted
- Pub. L. 112-144, tit. VI, sec. 602CLARIFICATION OF LEAST BURDENSOME STANDARD.Enacted
- Pub. L. 112-144, tit. VI, sec. 603AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.Enacted
- Pub. L. 112-144, tit. VI, sec. 604DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING.Enacted
- Pub. L. 112-144, tit. VI, sec. 605PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.Enacted
- Pub. L. 112-144, tit. VI, sec. 606CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.Enacted
- Pub. L. 112-144, tit. VI, sec. 607MODIFICATION OF DE NOVO APPLICATION PROCESS.Enacted
- Pub. L. 112-144, tit. VI, sec. 608RECLASSIFICATION PROCEDURES.Enacted
- Pub. L. 112-144, tit. VI, sec. 609HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND LABELING SYMBOLS.Enacted
- Pub. L. 112-144, tit. VI, sec. 610PARTICIPATION IN INTERNATIONAL FORA.Enacted
- Pub. L. 112-144, tit. VI, sec. 611REAUTHORIZATION OF THIRD-PARTY REVIEW.Enacted
- Pub. L. 112-144, tit. VI, sec. 612REAUTHORIZATION OF THIRD-PARTY INSPECTION.Enacted
- Pub. L. 112-144, tit. VI, sec. 613HUMANITARIAN DEVICE EXEMPTIONS.Enacted
- Pub. L. 112-144, tit. VI, sec. 614UNIQUE DEVICE IDENTIFIER.Enacted
- Pub. L. 112-144, tit. VI, sec. 615SENTINEL.Enacted
- Pub. L. 112-144, tit. VI, sec. 616POSTMARKET SURVEILLANCE.Enacted
- Pub. L. 112-144, tit. VI, sec. 617CUSTOM DEVICES.Enacted
- Pub. L. 112-144, tit. VI, sec. 618HEALTH INFORMATION TECHNOLOGY.Enacted
- Pub. L. 112-144, tit. VI, sec. 619GOOD GUIDANCE PRACTICES RELATING TO DEVICES.Enacted
- Pub. L. 112-144, tit. VI, sec. 620PEDIATRIC DEVICE CONSORTIA.Enacted
- Pub. L. 112-144, tit. VII, sec. 701REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.Enacted
- Pub. L. 112-144, tit. VII, sec. 702REGISTRATION OF FOREIGN ESTABLISHMENTS.Enacted
- Pub. L. 112-144, tit. VII, sec. 703IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT LISTING.Enacted
- Pub. L. 112-144, tit. VII, sec. 704ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.Enacted
- Pub. L. 112-144, tit. VII, sec. 705RISK-BASED INSPECTION FREQUENCY.Enacted
- Pub. L. 112-144, tit. VII, sec. 706RECORDS FOR INSPECTION.Enacted
- Pub. L. 112-144, tit. VII, sec. 707PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR REFUSING INSPECTION.Enacted
- Pub. L. 112-144, tit. VII, sec. 708DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT.Enacted
- Pub. L. 112-144, tit. VII, sec. 709ADMINISTRATIVE DETENTION.Enacted
- Pub. L. 112-144, tit. VII, sec. 710EXCHANGE OF INFORMATION.Enacted
- Pub. L. 112-144, tit. VII, sec. 711ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.Enacted
- Pub. L. 112-144, tit. VII, sec. 712RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.Enacted
- Pub. L. 112-144, tit. VII, sec. 713STANDARDS FOR ADMISSION OF IMPORTED DRUGS.Enacted
- Pub. L. 112-144, tit. VII, sec. 714REGISTRATION OF COMMERCIAL IMPORTERS.Enacted
- Pub. L. 112-144, tit. VII, sec. 715NOTIFICATION.Enacted
- Pub. L. 112-144, tit. VII, sec. 716PROTECTION AGAINST INTENTIONAL ADULTERATION.Enacted
- Pub. L. 112-144, tit. VII, sec. 717PENALTIES FOR COUNTERFEITING DRUGS.Enacted
- Pub. L. 112-144, tit. VII, sec. 718EXTRATERRITORIAL JURISDICTION.Enacted
- Pub. L. 112-144, tit. VIII, sec. 801EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.Enacted
- Pub. L. 112-144, tit. VIII, sec. 802PRIORITY REVIEW.Enacted
- Pub. L. 112-144, tit. VIII, sec. 803FAST TRACK PRODUCT.Enacted
- Pub. L. 112-144, tit. VIII, sec. 804CLINICAL TRIALS.Enacted
- Pub. L. 112-144, tit. VIII, sec. 805REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT INCENTIVES IN 5 YEARS.Enacted
- Pub. L. 112-144, tit. VIII, sec. 806GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG DEVELOPMENT.Enacted
- Pub. L. 112-144, tit. IX, sec. 901ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL TREATMENTS.Enacted
- Pub. L. 112-144, tit. IX, sec. 902BREAKTHROUGH THERAPIES.Enacted
- Pub. L. 112-144, tit. IX, sec. 903CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.Enacted
- Pub. L. 112-144, tit. IX, sec. 904ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER LABELS BY VISUALLY IMPAIRED AND BLIND CONSUMERS.Enacted
- Pub. L. 112-144, tit. IX, sec. 905RISK-BENEFIT FRAMEWORK.Enacted
- Pub. L. 112-144, tit. IX, sec. 906GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.Enacted
- Pub. L. 112-144, tit. IX, sec. 907REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.Enacted
- Pub. L. 112-144, tit. IX, sec. 908RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE PROGRAM.Enacted
- Pub. L. 112-144, tit. X, sec. 1001DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-SAVING DRUGS.Enacted
- Pub. L. 112-144, tit. X, sec. 1002ANNUAL REPORTING ON DRUG SHORTAGES.Enacted
- Pub. L. 112-144, tit. X, sec. 1003COORDINATION; TASK FORCE AND STRATEGIC PLAN.Enacted
- Pub. L. 112-144, tit. X, sec. 1004DRUG SHORTAGE LIST.Enacted
- Pub. L. 112-144, tit. X, sec. 1005QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.Enacted
- Pub. L. 112-144, tit. X, sec. 1006ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.Enacted