FDA Reauthorization Act of 2017

Sec. 1. Short title.

Sec. 2. Table of contents.

TITLE I— FEES RELATING TO DRUGS

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.

TITLE II— FEES RELATING TO DEVICES

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.

TITLE III— FEES RELATING TO GENERIC DRUGS

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.

TITLE IV— FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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.

TITLE V— PEDIATRIC DRUGS AND DEVICES

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.

TITLE VI— REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

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.

TITLE VII— DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

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.

TITLE VIII— IMPROVING GENERIC DRUG ACCESS

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.

TITLE IX— ADDITIONAL PROVISIONS

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.