The Food and Drug Administration issued its weekly Enforcement Report for Nov. 13 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 will allow another week for comments on its proposed rules on produce safety and risk-preventative controls for human foods. Comments on the two proposals will now be due Nov. 22, because of intermittent technical difficulties on the www.regulations.gov site that occurred in November that prevented some from submitting comments. Comments were originally due Nov. 15.
On Nov. 14 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 signed on to an international pilot program to accept medical device inspections by foreign governments and third-party auditors, said the agency in a Federal Register notice (here). Through the Medical Device Single Audit Program (MDSAP) International Coalition Program, regulators in Australia, Brazil, Canada, and the U.S. will accept audits of medical devices conducted by each foreign government, as well as by third-party auditors recognized by the coalition. Japan is participating as an observer. In the U.S., FDA will accept MDSAP audit reports as substitutes for routine inspections -- inspections conducted “for cause” or as a “compliance follow-up” won’t be affected. MDSAP is targeting June 2014 for the beginning of the pilot, with an eye to 2017 for the beginning of the operational program, FDA said (here).
On Nov. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 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 is reopening the comment period for another 30 days on its proposed update to a guidance document on medical foods. Topics covered by the draft guidance include the definition of medical foods and labeling requirements (including a prohibition on use of “Rx only” on medical foods labels) (see [Ref 13081522]). Comments were originally due Oct. 15. Industry had requested an extension of 60 days, but FDA said a shorter extension is sufficient because much of the frequently asked questions document is unchanged from a 2007 guidance. Comments are now due Dec. 16.
On Nov. 8 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 proposing to allow generic drug and biological product manufacturers to update safety labels without preapproval from FDA, in a move that would give generic drug companies the same flexibility as their brand-name counterparts. FDA’s proposed rule (here) would allow certain temporary labeling changes upon submission of a “changes being effected” document. FDA would then make a decision after the fact on whether to approve the labeling change. If approved, the change would also apply to the corresponding brand drug label, FDA said. Comments on the proposal are due by Jan. 13.
The Food and Drug Administration on Nov. 7 announced it intends to restrict sale of partially hydrogenated oils because of health concerns associated with trans fats (here). Although trans fats occur naturally in meat and dairy products and refined edible oils, partially hydrogenated oils have trans fats intentionally added as an integral component, explained FDA. A Center for Disease Control study showed elimination of partially hydrogenated oil from the food supply could prevent thousands of deaths from heart attacks annually, it said. Given that partially hydrogenated oils are no longer generally recognized as safe by scientists, FDA intends to reclassify them as food additives. If FDA finalizes the reclassification, food manufacturers would no longer be permitted to sell partially hydrogenated oils, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. FDA requested comments by Jan. 7 in a concurrent Federal Register notice (here).