FDA Review posts the Federal Register notices for the week ending 5/5/2019.
FDA approves a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot...
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.