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One Hundred Seventh Congress of the United States of America
Understanding 505(b)(2) Drug Development & API Supply Issues - LGM Pharma
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Approved Drug Products With Therapeutic Equivalence 40th Edition 2020 | U.S. Government Bookstore
FEDERAL FOOD, DRUG, AND COSMETIC ACT [As Amended Through P.L. 117–286, Enacted December 27, 2022] CHAPTER I—SHORT TITLE SECT
S. 3092
Federal Register :: Abbreviated New Drug Applications and 505(b)(2) Applications
Using 505(b)(2) to Solve Shortfall from Generic Cliff
At the end of the bill, add the following new section: 1 2 (a) BRAND NAME DRUGS.—Section 505(b)(2) of the 3 Federal Food, Drug
H. R. 5811
Referencing A Listed Drug For The 505(b)(2) Pathway
FDA Draft Guidance on PMRs - HCL Technologies
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guid
Federal Register :: Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability
The "New-Drug" Law
Regulations.gov
One Hundred Eighth Congress of the United States of America
H. RES. 5 6 9
115 STAT. 1408 PUBLIC LAW 107-109-JAN. 4, 2002 Public Law 107-109 107th Congress An Act
Federal Food, Drug, and Cosmetic Act
