News & Analysis as of

Innovative Technology › Comment Period › Pharmaceutical Industry

Wilson Sonsini Goodrich & Rosati

FDA Launches PreCheck and Advanced Manufacturing Technologies Designation Programs to Strengthen U.S. Drug Manufacturing

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently announced two initiatives to boost domestic pharmaceutical production. On August 7, 2025, the agency announced the voluntary FDA PreCheck Program to expedite review of new...more

Hogan Lovells

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

Hogan Lovells on

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

Polsinelli on

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide