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The Food and Drug Administration is withdrawing 23 out-of-date draft guidances, as part of a clean-up of its draft guidance documents issued before 2010. The draft guidances being withdrawn cover topics like drug development and approval, current good manufacturing practice (CGMP) requirements for drugs and labeling in abbreviated new drug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to FDA’s Center for Drug Evaluation and Research, FDA has in most cases developed other guidances to replace the withdrawn documents.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:
The Food and Drug Administration raised potential fiscal year 2014 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees. The FY 2014 fees of $237/hour for domestic services and $302/hour if foreign travel is required are higher than the FY 2013 fees of $221/hour and $289/hour, respectively. The fees are effective Oct. 1.
On July 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: