JD Supra

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...
chronicleonline.comOpinion

FDA’s labeling overhaul threatens to accelerate pharmacy closures

America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
JD Supra

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
wvgazettemail.comOpinion

David Bernstein: FDA's labeling overhaul threatens pharmacies (Opinion)

America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
The National Law Review

A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
MarketWatch

Cyberonics gets FDA OK for VNS labeling format

SAN FRANCISCO (MarketWatch) -- Cyberonics Inc. said Wednesday it has received approval from the Food and Drug Administration for an armonized/modularized VNS therapy system labeling format. The FDA ...
Houston Chronicle

(PRN) Cyberonics Receives FDA Approval for Harmonized/Modularized VNS Therapy System Labeling Format

HOUSTON, July 12 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that it received FDA approval for a harmonized/modularized VNS Therapy(TM ...