FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications while it evaluates the policy and works to establish a formal regulatory framework governing the disclosures.
FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing facility.
FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications while it evaluates the policy and works to establish a formal regulatory framework governing the disclosures.
FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing facility.
Former FDAer David Gertler says it’s time for the agency to resume the unannounced, in-person inspections of drug and medical device facilities that made FDA oversight the global gold standard.
Four stakeholders express varying opinions on the future direction and existence of the FDA national priority drug voucher program.
