FDA warns Indias Cipla Limited about CGMP violations in its production of finished drugs.
FDA warns Gojo Industries its Purell Healthcare Advanced Hand Sanitizer product line is considered an unapproved new drug that cannot be marketed unde...
FDA publishes a draft guidance on using flow restrictors for oral liquid drug products to limit unintentional ingestion by children.
FDA warns Indias Windlas Healthcare Private Limited about CGMP violations in its manufacturing of finished drugs.
FDA postpones a 4/16 advisory committee meeting that was to review a TransMedics PMA for the TransMedics Organ Care System.
Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports.
FDA updates a policy on diagnostic testing for coronavirus that allows states to take responsibility for tests developed and used by laboratories in t...
Federal Register: FDA debars Zhang Xiao Dong for five years from importing articles of food (including dietary supplements) or offering such articles ...