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FDA to Hold Workshop on New Drug Supply Chain Tracing Requirements
April 1, 2014 by Brian Feito|FDA

The Food and Drug Administration said it will hold a meeting May 8-9 in Silver Spring, Md., to discuss implementation of drug supply chain tracing provisions of the Drug Supply Chain Security Act. The “public workshop” will provide a forum for discussing the development of standards for the interoperable exchange of product tracing information, said FDA. Participants will also discuss the feasibility of establishing standardized documentation for product tracing purposes. Registration is required by April 24.

FDA Denver to Host Conference on Drug and Device Regulation in June
March 28, 2014 by Brian Feito|FDA

The Food and Drug Administration’s Denver district office will host a public workshop June 23-24 in Denver on “a number of topics” related to FDA’s regulation of drugs and medical devices. The “FDA and Global Engagement: Progress on the Pathway to Global Product Safety” workshop, a joint effort between FDA and the Association of Food and Drug Officials, will include information on contract manufacturing, compliance, recalls, and international regulations, said FDA. Registration is required by May 23, and costs $575 for non-association members. Hotel reservations must be made by May 21 to receive the reduced conference rate.

FDA Posts Draft Changes to Guidance on Prior Notice of Imported Food
March 28, 2014 by Brian Feito|FDA

The Food and Drug Administration posted to its website draft changes to its guidance on prior notice for imported foods. The agency hasn’t updated the questions and answers document since 2004, and in the meantime formally adopted the interim final rule that established prior notice requirements and issued another final rule requiring importers notify FDA if an article has previously been refused entry. Comments on the draft guidance may be submitted at any time, but should be filed by May 30 for consideration before FDA finalizes the guidance, said FDA in a concurrent Federal Register notice (here).