The Food and Drug Administration issued its weekly Enforcement Report for Feb. 20 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is issuing a proposed rule to finally put into effect a “monograph” for over-the-counter sunscreen that would set conditions for selling sunscreen in the U.S. without prior approval from the agency. The renewed effort follows a monograph for sunscreen issued in 1999 that never went into effect, but that forms the basis for FDA’s current policy of enforcement discretion for unapproved sunscreens that contain ingredients that were set to be recognized as safe in the rule (see 1805220043). The proposed rule would formally allow sale in the U.S. of sunscreens, without a new drug application, that contain certain ingredients recognized by FDA to be safe. Comments are due May 27.
On Feb. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 14 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The Food and Drug Administration posted a new draft guidance document on “nonbinding feedback” provided by the agency after inspections of device establishments. The draft guidance explains how device establishments may submit requests for nonbinding feedback to FDA on actions the company has proposed to take to address certain kinds of observations from FDA inspections. The document outlines a “standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests,” the agency said. Comments are due April 22.
On Feb. 13 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 Feb. 13 that lists 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 Feb. 11 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 recently issued its first warning letter for violations under the Drug Supply Chain Security Act, FDA Commissioner Scott Gottlieb said in a Feb. 12 statement. McKesson Corp., a U.S. distributor of pharmaceuticals, was cited for its failure to sufficiently respond to notifications from a pharmacy it supplied that there was illegitimate product in its supply chain -- opioid pills were missing from bottles that were distributed by McKesson -- and did not quarantine and investigate suspect products or maintain records of investigations of suspect product, Gottlieb said. “We’ll continue our efforts to help ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace medications -- including opioids -- as they move through the supply chain, and to respond to incidents involving illegitimate products in order to protect the public health,” Gottlieb said.