On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
7/17/2025
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Clinical Trials ,
Compliance ,
Disclosure Requirements ,
Drug Approvals ,
Drug Pricing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Investors ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Transparency
On June 16, the D.C. Circuit Court struck down the Centers for Medicare and Medicaid Services’ (“CMS”) rule issued in May 2019 requiring pharmaceutical companies to disclose the wholesale acquisition cost of drugs over $35 in...more
CMS finalized the Outpatient Prospective Payment System hospital price transparency rules on November 15, 2019. As of January 1, 2021, hospitals will have to publicly post (and update annually) two sets of data: first, a...more