FDA issues a draft guidance describing its approach to considering uncertainty in making benefit/risk decisions for some medical device applications.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.
Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry: Drug Supply Chain Security Act Impl...
The International Contrast Ultrasound Society says current safety information does not justify use of Boxed Warnings in the products labeling.
CDRH releases a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De N...
FDA commissioner Scott Gottlieb praises the growth of the agencys medical device Private Payor Program that aims to shorten the time between FDA appro...