FDA Reauthorization Act of 2017

openUnited States· United States Congress· EN

Introduced

25 April 2017

Last action

11 May 2017 · Reported

Status

Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.

Summary

FDA Reauthorization Act of 2017 Prescription Drug User Fee Amendments of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities. Medical Device User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill revises the types of medical devices that the FDA may accredit third parties to review. Generic Drug User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications. Biosimilar User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees. The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

25 April 2017
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
25 April 2017
Introduced
Introduced in Senate
Source: IntroReferral
11 May 2017
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
Source: Calendars
11 May 2017
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Source: Committee
11 May 2017
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Source: Committee

Votes

No vote records are attached yet.

Versions

Reported to Senate · 11 May 2017 · Download file
Introduced in Senate · 25 April 2017 · Download file

Documents

6 official files

Reported to Senate (text)

View file Download file

This file cannot be previewed here. Use View or Download.

Leesvertaling

Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

Vertaal naar

Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Reported to Senate (text)
Reported to Senate · EN · 11 May 2017
View Download Open at official source
Reported to Senate (PDF)
Reported to Senate · EN · 11 May 2017
View Download Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Reported to Senate with amendment(s)
summary · EN · 11 May 2017
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in Senate (text)
Introduced in Senate · EN · 25 April 2017
View Download Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in Senate (PDF)
Introduced in Senate · EN · 25 April 2017
View Download Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in Senate
summary · EN · 25 April 2017
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

related to → Over-the-Counter Hearing Aid Act of 2017
related to → Over-the-Counter Hearing Aid Act of 2017
related to ← Enhanced Clinical Trial Design Act of 2017
related to ← Opioid Addiction Risk Transparency Act
related to ← FDA Reporting Transparency and Accountability Act
related to ← Drug Diversion and Counterfeit Crackdown Act of 2017
related to ← Medical Device Safety Monitoring Act
related to ← Realizing Intended Safety for Certain Accessories Act of 2017
related to ← Pediatric Device Development Act
related to ← Making Pharmaceutical Markets More Competitive Act

Showing 10 of 12 related records.

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/115th-congress/senate-bill/934
Open data entity: https://api.congress.gov/v3/bill/115/s/934
us · 115-s-934 · source updated 5 December 2025