FDA on Jan. 12 signed a Mutual Recognition Agreement with Switzerland’s Agency for Therapeutic Products (Swissmedic) that will allow the U.S. and Switzerland to rely on each other’s inspections of pharmaceutical and veterinary drug facilities, avoiding the need for duplicate inspections, FDA said in a statement that day. Prior to the MRA’s entry into force, FDA still must “determine whether Swissmedic is capable of conducting inspections that meet U.S. requirements, and Swissmedic must make a similar determination with respect to the FDA meeting Swiss requirements,” FDA said. The MRA includes privisons on when the regulators intend to accept official good manufacturing practice documents from the other; how regulators will transmit the documents; and the establishment of two committees “to facilitate the effective functioning of the MRA,” said a release from the Office of the U.S. Trade Representative, which also signed the agreement.
On Jan. 12, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 10-11, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has issued its Enforcement Report for Jan. 11, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Jan. 5-9, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA finalized its guidance document on Foreign Supplier Verification Program requirements for food importers. Released Jan. 10, the final guidance includes revisions to a draft guidance issued in 2018 (see 1801240029), with “additional clarification regarding to what food the FSVP regulation applies; what information must be included in the FSVP; and who must develop and perform FSVP activities,” FDA said in a constituent update.
On Jan. 4, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has issued its Enforcement Report for Jan. 4, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Jan. 3, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 29, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: