On July 25-26 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 set potential fiscal year 2019 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, it said in a notice. The agency set FY19 fees of $253/hour for domestic services involving travel and $282/hour if foreign travel is required. The fees are effective Oct. 1.

On July 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On July 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On July 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On July 19 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 is forming a work group to consider allowing the importation of foreign versions of drugs in cases of U.S. supply chain disruptions, FDA Commissioner Scott Gottlieb said in a July 19 statement. For “sole-source” drugs with a single manufacturer, FDA will look at allowing short-term importation of foreign versions of drugs if there are no blocking patents or exclusivities associated with those drugs, he said. Currently, supply chain disruptions related to sole source drugs can cause significant price increases that render the drugs unavailable. Short-term importation of foreign drugs may “help meet near-term patient need in the U.S. until new competition is able to enter the domestic market,” he said. The Healthcare Distribution Alliance criticized the idea in a statement. Importation of foreign versions would “threaten and destabilize” industry-government collaboration on pharmaceutical supply chain safety and security, in particular implementation of the Drug Supply Chain Security Act, HDA said.

On July 18 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 18 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

On July 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: