The Food and Drug Administration is extending the deadline for comments on its proposal to liberalize requirements for labeling changes on generic drug and biological products. The Nov. 13 proposed rule would allow generic drug and biological product manufacturers to update safety labels without preapproval from FDA, which would give generic drug companies the same flexibility as their brand-name counterparts (see 13111213). FDA is also amending its proposal to add references to its analysis of the change’s impact. Comments on the proposed rule are now due by March 13, and comments on information collection issues related to the proposed rule are due by Feb. 11.
During the week of Dec. 16-22, 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:
Negative feedback from industry will prompt “significant changes” from the Food and Drug Administration to its proposed rules on produce safety and preventative controls at food facilities. An agency statement dated Dec. 19 said the current iterations of the proposals would be too burdensome on farmers and other food producers. Because of the magnitude of the changes, FDA will publish revised proposed rules by early summer 2014, it said. The agency will seek comment only on areas of the proposed rules that change.
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 18 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Dec. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 17 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 allowing more time for comments on its draft risk profile on pathogens and filth in spices. The draft risk profile identifies the most commonly occurring hazards and filth and spices, the prevalence of these risks at different points along the supply chain, and mitigation and control options, including future possibilities and areas for more research (see 13110101). FDA has said it will be used by agency staff to inform regulatory decisions on spices. Comments are now due March 3.
On Dec. 16 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 Dec. 9-15, 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:
On Dec. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: