The Food and Drug Administration issued its weekly Enforcement Report for July 12 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
The Food and Drug Administration announced the availability of new and revised draft guidances on drug products, it said (here). The draft guidances (here) provide "product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)," FDA said. New draft guidances cover Aspirin; Aspirin (omeprazole); Brexpiprazole; Brivaracetam; Cefdinir; Clocortolone pivalate; Cyanocobalamin; Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir; Dextroamphetamine sulfate; Diclofenac sodium; Fluphenazine hydrochloride; Gentamicin sulfate; Glycopyrrolate; Obeticholic acid; Silver sulfadiazine; Tenofovir alafenamide fumarate; Tiopronin; Tipiracil hydrochloride; Trifluridine; Triamcinolone acetonide (multiple reference listed drugs); and Uridine triacetate. FDA has revised its draft guidances on Brimonidine tartrate; Dabigatran etexilate mesylate; Dorzolamide hydrochloride; Gefitinib Latanoprost; Methoxsalen; Metoprolol tartrate; Minocycline HCl (multiple reference listed drugs); Minoxidil; Pimozide; Propafenone hydrochloride; and Tetrabenazine.
On July 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for July 5 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On June 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for June 28 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.