Biologics Price Competition and Innovation Act (BPCIA)

Biologics Price Competition and Innovation Act of 2009 (“BPCIA”)

H. R. 3590-686

LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR INTERCHANGEABLE.—Section 351 of the Public Health Service Act (PHSA) (42 U.S.C. 262)

• Download BPCIA in PDF at https://www.fda.gov/media/78946/download

H. R. 3590-686: Patient Protection and Affordable Care Act (PPACA) in PDF

• Download PPACA in PDF (974 pages) at https://www.hhs.gov/sites/default/files/ppacacon.pdf

Federal Food, Drug, and Cosmetic Act (FD&C Act of 1938; FFDCA, FDCA or the Act)

[As Amended Through P.L. 113–5, Enacted March 13, 2013]

You may register and download the following statutes.   The FD&C Act consists of 692 pages (as amended on April 24, 2013).

FEDERAL FOOD, DRUG, AND COSMETIC ACT (FD & C Act or the Act) [As Amended Through P.L. 113–5, Enacted March 13, 2013]

• CHAPTER I—SHORT TITLE
• CHAPTER II—DEFINITIONS
• CHAPTER III—PROHIBITED ACTS AND PENALTIES
• CHAPTER IV—FOOD
• CHAPTER V—DRUGS AND DEVICES
• CHAPTER VII: GENERAL AUTHORITY
• CHAPTER IX: TOBACCO PRODUCTS
• SUBCHAPTER IX – TOBACCO PRODUCTS
• CHAPTER X: MISCELLANEOUS

Register and Download in PDF here >>

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

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.

• Register and Download in PDF here >>

Last Updated: 2020-06-07