FDA withdraws three Sun Pharmaceutical Industries ANDAs because they are no longer marketed.
Federal Register notice: FDA withdraws the approval of nine ANDAs from multiple applicants.
Federal Register notice: FDA issues a final order to reclassify the needle destruction device into Class 2 (special controls)and subject to premarket ...
FDA clears a PeraHealth 510(k) for the PeraTrend, a predictive, real-time clinical surveillance technology.
CDRH proposes a complete overhaul of its medical device review, safety surveillance and compliance structure to move to a more total product lifecycle...
FDA releases the FDA-483 with four observations from a 12/4-12/12/17 inspection at Switzerlands Akorn AG drug manufacturing facility.
FDA issues a document answering industrys questions on the agencys clinical data summary pilot program.
FDA releases an FDA-483 with six observations following an inspection at Infuscience, a sterile drug product producer in Eagan, MN.