Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy products.
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical D...
FDA clears an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation.
Beaumont Bio Med recalls its entire aqueous/alcohol-based product line due to possible microbial contamination.
FDA issues a draft guidance describing its approach to considering uncertainty in making benefit/risk decisions for some medical device applications.
FDA publishes guidances to assist sponsors in developing drugs to treat allergic rhinitis and nonallergic rhinitis.
CDER issues a MAPP on policies and procedures for the site selection model used by the Office of Surveillance to prioritize manufacturing sites for ro...
A new analysis commissioned by PhRMA shows that about one in five hospitals marks up medicine prices 700% or more.