The Food and Drug Administration is once again extending the period for comments on its preventative controls (here) and produce safety (here) rules, this time until Nov. 15. The 60-day extension will allow for consideration of the food safety standards in the context of the Foreign Supplier Verification Program (FSVP) and third-party auditor accreditation proposals, published July 29 (see 13072623). “This is the second and final extension of the comment period for these two rules,” FDA said. The agency had already allotted more time for comments in April (see 13042421).
On Aug. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 5 the Food and Drug Administration posted a new and revised version of the following Import Alerts on the detention without physical examination of:
During the week of July 30 - Aug. 5, 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:
The Food and Drug Administration is withdrawing 23 out-of-date draft guidances, as part of a clean-up of its draft guidance documents issued before 2010. The draft guidances being withdrawn cover topics like drug development and approval, current good manufacturing practice (CGMP) requirements for drugs and labeling in abbreviated new drug applications (ANDAs). According to FDA’s Center for Drug Evaluation and Research, FDA has in most cases developed other guidances to replace the withdrawn documents.
On Aug. 2-4 the Food and Drug Administration posted a new and revised version of the following Import Alerts on the detention without physical examination of:
On Aug. 1 the Food and Drug Administration posted a new and revised version of the following Import Alert on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for July 31 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 is adopting a voluntary definition for “gluten-free” foods, in a final rule set for publication Aug. 5. Under the new requirements, food may be marked “gluten-free” if it inherently contains no gluten, or if it has been refined to remove gluten. Any food that claims "gluten-free," “no gluten,” “free of gluten”, or “without gluten” but doesn’t meet FDA’s new gluten-free requirements will be considered by the agency to be misbranded, FDA said. The final rule is effective Sept. 4.
On July 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: