On March 17-18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 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 its weekly Enforcement Report for March 15 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
The Food and Drug Administration is delaying the effective date of a final rule that clarified when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said (here). Under the final rule, issued Jan. 9, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000" (see 1701060011). Originally effective March 21, 2017, the final rule will now take effect March 19, 2018, FDA said. The agency will take the extra time to consider a petition from industry, including by seeking more comments on the final rule, it said.
The Food and Drug Administration recently asked for comments on a proposed list (here) of class II medical devices that will be exempt from premarket notification requirements once the list is finalized. The 21st Century Cures Act, enacted in December, requires FDA to publish the final list by 210 days after enactment and then every five years. Comments on the draft list are due May 15.
On March 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 10-11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: