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.

The Food and Drug Administration issued guidance on how exporters of milk and milk products, seafood, infant formula and formula for young children can meet new establishment certification requirements required for export to China, it said (here). The revised guidance document, which previously covered only milk, “explains how establishments should apply to be included on FDA’s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information,” the agency said. FDA recently signed a memorandum of understanding with China establishing a formal registration process after the Chinese government issued a decree requiring “certification of compliance with the relevant standards, laws, and regulations of China” as of June 15 for milk and milk products, seafood, infant formula and formula for young children. FDA will use the information it receives from exporters “to establish and update a list of eligible exporters in a manner consistent with the MOU, and the agency will update the list of establishments and products four times per year,” it said.