Multiple Coronavirus Vaccines Is Policy Aim, But Will Complicate Supply Chain
Executive Summary
At Senate hearing, FDA and NIH officials say government and vaccine developers are outlining production needs with ability to shift manufacturing from their candidates to others to ensure production of the most promising products. FDA Commissioner Hahn says as an essential worker he would break quarantine if needed at a critical White House or other meeting.
You may also be interested in...
US FDA May Grant More Emergency Use Authorizations For COVID-19 Treatments This Fall
Convalescent plasma, anti-inflammatory agents among those that could be considered for EUAs, Commissioner Hahn says during congressional hearing on the coronavirus response.
When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No
Bob Temple tells the Pink Sheet that many of the drugs that sponsors are bringing forward have “not much evidence” of antiviral properties, “but it's still worth trying.” Jacqueline Corrigan-Curay emphasizes that even as FDA responds to the enormous coronavirus challenge, the agency's other work continues.
US FDA Pushing Coronavirus Trial Sponsors To Include Control Groups
“We still try hard to get people to have a control group,” Bob Temple says in an interview. “Not everybody always wants to have a control group. We've been trying hard to do it.”