S 1477 · 104th Congress · Health

Food and Drug Administration Performance and Accountability Act of 1996

Introduced 1995-12-13· Sponsored by Sen. Kassebaum, Nancy Landon [R-KS]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: An errata sheet on written report No. 104-284 was printed.(1996-06-20)

Plain Language Summary

[AI summary unavailable — showing source text] TABLE OF CONTENTS: Title I: Mission and Accountability Title II: Expedited Access to Products for Seriously Ill Patients Title III: Revitalizing the Investigation of New Products Title IV: Efficient, Accountable, and Fair Product Review Title V: Drug, Biological Products, Devices Export Reform Title VI: Drug and Biological Products Regulatory Reform Title VII: Device Regulatory Reform Title VIII: Animal Drug Regulatory Reform Title IX: Food Regulatory Reform Food and Drug Administration Performance and Accountability Act of 1995 - Title I: Mission and Accountability - Food and Drug Administration Regulatory Reform Act of 1995 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth a Food and Drug Administration (FDA) mission statement. (Sec. 103) Mandates: (1) performance standards for FDA product reviews; (2) an applicant-accessible information system; and (3) a procedure regarding policy statements of general applicability. (Sec. 106) Authorizes the Commissioner of Food and Drugs to delegate authority related to scientific review groups to a center director. (Sec. 107) Requires an intra-FDA appeal system. Empowers any person to request an evaluation by a scientific …

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (4)

4 Republicans