On Sept. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Goods should, as a matter of policy, be automatically released from FDA detention upon approval of the New Drug Application/Therapeutic Biologic Application (BLA)/Abbreviated New Drug Approvals are approved, said the American Association of Exporters and Importers in comments on the FDA's Draft Guidance for Industry on Pre-Launch Activities Importation Requests (PLAIR) for drugs. AAEI also said importers should be allowed to distribute product as soon as the NDA/BLA/ANDA is approved, without additional FDA action, such as release from detention.
On Sept. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 19 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 issued its weekly Enforcement Report for Sept. 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 Sept. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 16 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 issued the Interstate Certified Shellfish Shippers List (ICSSL) for September. 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 Food and Drug Administration said it plans to update forms required by processors of Low-Acid Canned Foods. Old FDA Forms 2541a and 2541c will be replaced by four new forms that are specific to different industry manufacturing practices, FDA said. The changes will make It easier for processors to submit information on manufacturing processes to FDA, the agency said. The switch to the new forms won’t happen until FDA has had a chance to request and review comments. Until then, low-acid canned food manufacturers should continue to use the old forms, FDA said.