A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Courts Loper Bright de...
FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.
FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys production of injectable we...
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standa...
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they...
