Category: Regulatory/FDA

EHRNEWS

10/25/2021

FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key

FDA-News (2)

10/11/2021

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

EHRNEWS

10/04/2021

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

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