The Food and Drug Administration issued its weekly Enforcement Report for May 11 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 March 30 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 a new edition of its guidance document on medical foods (here). The second edition of its guidance titled “Frequently Asked Questions About Medical Foods” gives “responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance,” said FDA in its announcement of the new guidance (here). Medical foods are “specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone,” said FDA.

On May 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 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 May 4 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 will hold three one-day public meetings in June to discuss its implementation of “prevention-oriented import safety programs” under the Food Safety Modernization Act, it said (here). At meetings on June 7 in Costa Mesa, Calif., June 15 in Rutherford, N.J., and June 21 in Detroit, Mich., FDA will give importers the chance to have an “in-depth discussion” on implementation of the Foreign Supplier Verification Program (FSVP), regulations on third-party certification bodies, and the Voluntary Qualified Importer Program (VQIP). FDA officials and importers will discuss the “next phase” of implementation, “which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance,” said FDA. Registration is (here).

On May 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: