Category: Regulatory/FDA

vaccine.News

09/27/2021

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

CHC_FDA-Regulatory Images2

09/20/2021

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

FDA-News (1)

08/30/2021

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

CHC_FDA-Regulatory Images2

08/10/2021

FDA Accepting Comment on Burden of Drug Advertising, HCEI Communications Disclosures

CHC_general2

07/29/2021

OPDP To Study Impact of Exhibit Booth Materials, Medical Conference Conversations on HCPs

07/26/2021

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

CHC_general1

07/12/2021

CDER Approves 27 Novel Drugs in First Half of 2021

headshot_kate.NEWS (1)

06/11/2021

FDA at Turning Point: Kate Rawson Explains

Cavazzoni.News

06/07/2021

The Real FDA Leadership Story Is New CDER Director Dr. Patrizia Cavazzoni