FDA publishes a draft guidance revising a recent draft on quality considerations for topical ophthalmic drugs.
FDA warns Sarasota, FL-based Omeza about CGMP violations in its production of unapproved and misbranded over-the-counter drugs.
FDA issues a complete response letter for the Merck resubmitted NDA for gefapixant, saying the drug did not establish substantial evidence of efficacy...
Medline Industries recalls some lots of tracheostomy care and cleaning trays following complaints.
FDA says Insight Pharmaceuticals is recalling one lot of its Americaine benzocaine topical anesthetic spray due to the presence of benzene from the ca...
FDA warns Brooklyn, NY-based Hua Da Trading that it is illegally marketing a misbranded unapproved drug containing the active ingredient in Viagra as ...
FDA says Hospira has recalled one lot of bleomycin for injection following a confirmed report of glass particulate in one vial.
FDA warns Fresenius Medical Care Holdings about Quality System regulations violations in its work as a specification developer for the companys North ...
