The Food and Drug Administration issued its weekly Enforcement Report for July 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
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:
The Food and Drug Administration will ask the Northern California U.S. District Court to reconsider its deadlines for two of the seven Food Safety Modernization Act deadlines, according to a July 19 court filing. The district court had ordered FDA to propose all seven rules required by FSMA by Nov. 30, with final versions due by June 2015 (see 13062412). But the FDA says meeting the November deadline for two of the proposed rules -- sanitary transport and intentional adulteration -- will be impossible.
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:
The Food and Drug Administration is asking for comments by Sept. 23 on a newly-posted draft guidance on Pre-Launch Activities Importation Requests (PLAIR) for drugs (here). PLAIRs are used to import unapproved finished dosage form drug products when the importer anticipates imminent approval of a new drug application or abbreviated new drug application. Under the PLAIR, unapproved may be imported for relabeling or reconditioning, but are considered to be detained by FDA and so cannot enter into U.S. commerce. Historically, FDA has used examined PLAIRS on a case-by-case basis, but the agency is now creating a formal program, it said. The draft guidance outlines what information should be submitted to FDA in a PLAIR, when and how a PLAIR can be submitted, and the circumstances under which FDA will grant a PLAIR.
On July 22 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 July 15-22, 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 published its tentative schedule for upcoming rulemakings, as part of the Spring 2013 Unified Agenda. According to the plan, proposed rules on the Foreign Supplier Verification Program and third-party food safety auditor accreditation, required by the Food Safety Modernization Act, are to be published in July 2013. As of July 22, both proposed rules are still under Office of Management and Budget Review.
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:
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: