OR WAIT null SECS
December 31, 2020
A report in the New England Journal of Medicine states preliminary results from a Phase III clinical trial shows the vaccine is 94.1% effective.
Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.
December 30, 2020
President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.
December 23, 2020
The agency is targeting websites that market untested CBD products as medical treatments.
Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.
The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.
December 21, 2020
The guidance provides information on review timelines during the COVID-19 pandemic.
December 18, 2020
The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.
The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.
FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.