Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more
On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more
On November 16, 2021, U.S. House Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the highly anticipated Cures 2.0 Act (H.R. 6000). Among other things, this 173-page bipartisan bill contain provisions to...more
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more
9/21/2016
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Classification ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Manufacturers ,
MDRP ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Rebates
In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more
6/19/2013
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
SCOTUS