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.
FDA releases the form FDA-483 with eight observations from an inspection 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.
FDA releases the form FDA-483 with eight observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing facility.
FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, CA drug manufacturing facility.
A Ropes & Gray legal update examines FDA initiatives to shorten drug development timelines and reduce regulatory burdens for sponsors.
