OR WAIT null SECS
December 31, 2020
FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.
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
Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.
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.
December 16, 2020
The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.