News & Analysis as of

Generic Drugs › Food and Drug Administration (FDA) › Proposed Amendments

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

Smart & Biggar on

Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

Sheppard Mullin Richter & Hampton LLP

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

Sheppard Mullin Richter & Hampton LLP on

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

2 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