Category: Regulatory/FDA

Nancy Myers.NEWS

01/24/2022

Myers: FDA Priorities Persist Amid Challenges

CHC_general1

01/10/2022

Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

FDA-News (2)

01/04/2022

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

CDER.News

12/13/2021

CDER Steps in to Issue Warning Letters for Vaping Products Deemed Drugs

FDA-News (2)

12/06/2021

FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

FDA-News (2)

11/08/2021

OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

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FDA Draft Guidance for Real-world Data: Documentation of Data Approach Is Key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Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD