The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for October. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Northern California U.S. District Court rejected on Oct. 21 the Food and Drug Administration’s attempt to delay the court’s Nov. 30 deadline for the agency’s intentional adulteration proposed rule. FDA had asked for a stay of the deadline for the Food Safety Modernization Act-required rulemaking while the U.S. Court of Appeals for the 9th Circuit hears the case. FDA has also filed a request for an “emergency stay” of the Nov. 30 intentional adulteration deadline with the appellate court.
The Food and Drug Administration ended its Centralized Entry Review Pilot on Sept. 30 as a result of the partial government shutdown, said CBP in a CSMS message. The pilot, which is hoped to help improve efficiency of document reviews by centralizing the agency's entry review resources, was originally scheduled to continue through Nov. 2 (see 13061915).
On Oct. 21 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The Food and Drug Administration is asking for comments by Dec. 23 on a new draft guidance on elemental impurities in pharmaceutical products. The draft guidelines (here), agreed to by the joint U.S.-European Union-Japan International Conference on Harmonization, would set safety limits for specific elements, and emphasizes control of supply chains and risk assessments, FDA said. The joint standard would set consistent expectations for test requirements and regulatory filings among the three ICH countries, said FDA.
On Oct. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 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 will still hold its public meeting on the Foreign Supplier Verification Program and third-party auditor accreditation proposed rules in Long Beach, Calif., Oct. 22 and 23. The agency had to cancel a similar meeting Oct. 10-11 in Miami due to the federal government shutdown (see 13100803). FDA posted an agenda for the Long Beach meeting (here).
On Oct. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: