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 are released to protect confidential commercial information.
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 are released to protect confidential commercial information.
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of personalized gene-edited therapies for rare diseases.
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gilead’s Descovy.
