FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology announce the availability of voluntary, standardized du...
FDA Review posts the Federal Register notices for the week ending 2/23/2018.
Federal Regiser notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed.
FDA releases an FDA-483 issued after an inspection at a Hospira sterile drug manufacturing plant.
Avalere Health identifies three steps it says FDA can take to facilitate interchangeable biosimilar applications and approvals.
FDA releases an 11-item FDA-483 issued following an inspection at a Bayer Pharma plant in Germany.
FDA releases a FDA-483 following an Indoco Remedies, Goa, India, inspection with eight inspection observations.
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.'s Zydelig (idelalisib) is 2...