On Sept. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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:
On Sept. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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New Drug Approvals are approved, said the American Association of Exporters and Importers in comments on the FDA's Draft Guidance for Industry on Pre-Launch Activities Importation Requests (PLAIR) for drugs.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: