The Food and Drug Administration issued its weekly Enforcement Report for Nov. 1 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 will recognize inspections of pharmaceutical manufacturing facilities by eight countries in the European Union, it said. The agency has determined that regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom are “capable of conducting inspections of manufacturing facilities that meet FDA requirements,” it said. FDA will begin relying on data from inspections by those countries to determine the compliance of pharmaceutical and pharmaceutical ingredient manufacturers beginning Nov. 1, it said.
The Food and Drug Administration is proposing to revoke a regulation authorizing the use on food labeling of health claims that eating soy protein reduces the risk of heart disease, it said. According to the agency’s proposed rule, evidence has emerged since the health claim was authorized in 1998 that contradicts the finding that soy protein encourages heart health. If FDA finalizes its rule, it “intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease,” FDA Center for Food Safety and Nutrition Director Susan Mayne said in a statement. “A qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.”
On Oct. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 25 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 Oct. 25 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Oct. 23 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 two guidance documents to clarify when a new 510(k) premarket submission is required when changes are made to existing medical devices. One new guidance document explains when software changes to existing devices require submission of a new 510(k). FDA also updated an existing guidance document on when other types of changes to existing devices require a new 510(k). The guidance documents are “not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required” for changes to existing devices, the agency said. The guidance documents are instead intended to “enhance the predictability, consistency, and transparency of the 'when to submit' decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision, specifically as it relates to software changes,” it said.
The Food and Drug Administration posted a new web page with a timeline of compliance dates for its Food Safety Modernization Act regulations. The agency also added a new graphical timeline for compliance dates under FSMA, including for human and animal food preventive regulations, produce safety regulations and the Foreign Supplier Verification Program. The next compliance date for FSMA is Jan. 26, when produce safety requirements take effect for small sprout farms and large farms of other produce.