FDA Reauthorization Act of 2017

Pub. L. 115-52

Also known as: Biosimilar User Fee Amendments of 2017, Generic Drug User Fee Amendments of 2017, Medical Device User Fee Amendments of 2017, Prescription Drug User Fee Amendments of 2017

47 sections of the Code credited to this law, found between Public Law 115-51 and Public Law 115-55.

• 21 U.S.C. § 333 — Penalties
• 21 U.S.C. § 351 — Adulterated drugs and devices
• 21 U.S.C. § 355 — New drugs
• 21 U.S.C. § 355–1 — Risk evaluation and mitigation strategies
• 21 U.S.C. § 355a — Pediatric studies of drugs
• 21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products
• 21 U.S.C. § 355c–1 — Report
• 21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
• 21 U.S.C. § 355g — Utilizing real world evidence
• 21 U.S.C. § 356g — Standards for regenerative medicine and regenerative advanced therapies
• 21 U.S.C. § 356h — Competitive generic therapies
• 21 U.S.C. § 356i — Prompt reports of marketing status
• 21 U.S.C. § 360 — Registration of producers of drugs or devices
• 21 U.S.C. § 360c — Classification of devices intended for human use
• 21 U.S.C. § 360d — Performance standards
• 21 U.S.C. § 360e — Premarket approval
• 21 U.S.C. § 360e–1 — Pediatric uses of devices
• 21 U.S.C. § 360e–3 — Breakthrough devices
• 21 U.S.C. § 360i — Records and reports on devices
• 21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
• 21 U.S.C. § 360m — Accredited persons
• 21 U.S.C. § 360n — Priority review to encourage treatments for tropical diseases
• 21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions
• 21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 21 U.S.C. § 360bbb–0 — Expanded access policy required for investigational drugs
• 21 U.S.C. § 360bbb–5 — Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb–8c — Patient participation in medical product discussion
• 21 U.S.C. § 374 — Inspection
• 21 U.S.C. § 379d–3 — Streamlined hiring authority
• 21 U.S.C. § 379h — Authority to assess and use drug fees
• 21 U.S.C. § 379h–2 — Reauthorization; reporting requirements
• 21 U.S.C. § 379i — Definitions
• 21 U.S.C. § 379j — Authority to assess and use device fees
• 21 U.S.C. § 379j–1 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–12 — Authority to assess and use animal drug fees
• 21 U.S.C. § 379j–41 — Definitions
• 21 U.S.C. § 379j–42 — Authority to assess and use human generic drug fees
• 21 U.S.C. § 379j–43 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–51 — Definitions
• 21 U.S.C. § 379j–52 — Authority to assess and use biosimilar biological product fees
• 21 U.S.C. § 379j–53 — Reauthorization; reporting requirements
• 21 U.S.C. § 379k–1 — Electronic format for submissions
• 21 U.S.C. § 381 — Imports and exports
• 21 U.S.C. § 384e — Recognition of foreign government inspections
• 21 U.S.C. § 393a — Office of Pediatric Therapeutics
• 42 U.S.C. § 262 — Regulation of biological products
• 42 U.S.C. § 284m — Program for pediatric studies of drugs