News & Analysis as of

Citizen Petitions UAW

Goodwin

BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

Goodwin on

FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations...more

Goodwin

FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

Goodwin on

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA...more

Goodwin

GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

Goodwin on

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more

Goodwin

FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

Goodwin on

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more

4 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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide