The Food and Drug Administration on Oct. 31 announced two actions aimed at preventing and resolving drug shortages. An FDA proposed rule (here) would set requirements for manufacturers of drugs or biological products to notify FDA of any permanent discontinuance or interruption in production if the lapse is likely to lead to a “meaningful disruption in supply.” A concurrently released strategic plan (here) outlines steps FDA can take in preventing or mitigating shortages, including the exercise of temporary enforcement discretion and cooperation with foreign governments to bring in temporary imports.
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 30 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 announced the availability of a new draft risk profile on pathogens and filth in spices (here). The assessment would be used by FDA staff to inform their regulatory decision-making related to the safety of spices in the U.S. food supply, said FDA in a Federal Register notice (here). The risk profile identifies the most commonly occurring hazards and filth and spices, as well as the prevalence of these risks at different points long the supply chain. It also identifies mitigation and control options, including future possibilities and areas for more research, said a Center for Food Safety and Applied Nutrition Constituent Update (here). Comments on the draft risk profile are due by Jan. 3.
The Food and Drug Administration is asking for comments by Dec. 31 on issues related to the collection of information through the prior notice requirement for imported food. The Office of Management and Budget requires agencies to periodically get approval for information they collect from the public. FDA is requesting an extension of approval for its prior notice requirements, and incorporating a change made in 2011 (and adopted in 2013 in final form) that importers must declare any country that has refused their products.
On Oct. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 21-28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: