OR WAIT null SECS
September 14, 2020
The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.
September 08, 2020
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
August 24, 2020
FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.
August 20, 2020
A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.
August 10, 2020
The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.
August 03, 2020
As biopharma companies and research institutes work to develop vaccines against COVID-19, policy makers and health officials debate strategies for ensuring fair and equitable distribution of anticipated preventives.
August 02, 2020
Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
July 24, 2020
Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.
July 21, 2020
Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?
July 20, 2020
Industry should be seeking more information from FDA on how it will restart its current inspection program.