More than 102 million U.S. households own a dog or a cat, and thousands more have fish, birds, or reptiles. The resulting pet ...
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...
Beijing Tsingke Biotech Co., Ltd. officially announced the appointment of Dr. Yaning Wang, a former senior expert at the FDA, ...
King was heavily criticized by vaping lobbyists for ordering thousands of companies to withdraw their fruit and ...
FDA guidance followed in February 2012 ... This is the focus of biosimilar regulation. HB: One of the biggest challenges for start-up biotech companies is in understanding regulatory requirements ...
Recently, Beijing Tsingke Biotech Co., Ltd. officially announced the appointment of Dr. Yaning Wang, a former senior expert ...
By Steven Grossman Secretary Kennedy’s announcement came last Thursday: FDA’s contribution to the pending HHS reduction in force (RIF) would ...
As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT ...
Medical Device Network on MSN1d
AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assayAliveDx has submitted a 510(k) premarket notification seeking approval from the FDA for its MosaiQ AiPlex CTDplus microarray.
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
"The ongoing gutting of the FDA is likely to cause American deaths," said the CEO of one medical device developer.
The Hatch Waxman Act and the Biological Price Competition and Innovation Act have incentivized efforts to improperly prolong ...
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