Exporters of active pharmaceutical ingredients to the EU will avoid burdensome certification requirements, after the European Commission declared the U.S. a “listed” country June 21 (here). Without the waiver, all U.S. companies shipping APIs to Europe after July 1 would have had to first submit documentation from the Food and Drug Administration that the product was manufactured in accordance with Europe’s good manufacturing practices, FDA said.

On June 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 issued its weekly Enforcement Report for June 19 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration revised a list of ports of entry that will participate in the centralized entry review pilot (see 13061915), said CBP in a CSMS message. The revised list of port numbers are: 2095, 2791, 2792, 2795, 2870, 2895, 3195, 3196, 4670, 4671, 5295, 5296, 5297, and 5298.

On June 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 will hold a meeting on implementation of certain provisions of the Food and Drug Administration Safety and Innovation Act, including standards for admission of imported drugs and commercial drug importers. The July 12 meeting in Silver Spring, Md., will include a general overview on FDASIA's Title VII supply chain integrity protections. FDA will also ask for input on the types of information that importers should be required to provide as a condition of admission, as well as registration requirements for commercial drug importers and good importer practices.

On June 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 12 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 12 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.