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...
FDA publishes a question-and-answer document to clarify provisions of the harmonized Q11 guidance on development and manufacture of drug substances.