The Food and Drug Administration intends to use DUNS numbers assigned by Dun and Bradstreet as Unique Facility Identifiers for domestic and foreign drug facility registration required by the Food and Drug Administration Safety and Innovation Act (FDASIA), it said in a draft guidance (here) posted Sept. 4. DUNS numbers (here) are free and are already widely used for drug registration, and meet agency needs, FDA said. The draft guidance only applies to registration requirements found in Sections 701 and 702 of FDASIA, and not to registration requirements for excipient manufacturers in Section 703 of the law. Comments on the draft guidance are due by Nov. 5

On Aug. 30 - Sept. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 28 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 Aug. 28 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

On Aug. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Intermittent issues on Aug. 27 related with the Food and Drug Administration's application for manually reviewing entries may lead to delays beyond routine time frames in processing entries, CBP said. According to CBP, these issues are being investigated and district personnel have experienced higher caller volume as a result.

On Aug. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

During the week of Aug. 20-26, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:

The Food and Drug Administration asked for notification of all imports of laser products so the agency can review admissibility, in an Aug. 12 letter to CBP. That includes informal and Section 321 low value entries, FDA said. The request for CBP notification is in response to mail and courier shipments of laser pointers that have been misdeclared as toys and flashlights to circumvent review, FDA said. The food, drug and device regulator needs to check if the laser pointers meet maximum energy output standards, it said.