SILVER SPRING, Md. , Aug. 13, 2024 /PRNewswire/ -- Today, the U.
S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted two warning letters issued to BullyKamp Products LLC and Top Dog Pet Store LLC dba The Bulldog Cartel , for marketing unapproved animal drugs intended for dogs, in violation of federal law. Because the unapproved animal drugs have not been submitted to the FDA for review, the agency is unable confirm whether they are safe, effective, properly manufactured, or if they contain the ingredients stated on the labels, in the quantities stated on the labels.
On Monday, the FDA announced that it will hold a public meeting on October 16, 2024 , titled, "Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub." The meeting is to discuss the establishment of the Rare Disease Innovation Hub (or "the Hub"), which will enhance collaboration and cooperation across the FDA's Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, as well as other centers and offices across the FDA, to advance rare disease therapies. The meeting, which will be facilitated by the Reagan-Udall Foundation, will provide those in the rare disease community the opportunity to provide input on the priorities of the Hub.
Information on the meeting, including topics for discussion and how to register, may be found here . On Friday, the FDA approved Yorvipath (palopegteriparatide) in.