Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Laura Helbling
US FDA’s Pharmacy Compounding Advisory Committee agrees with AbbVie that liposomal drugs and products using hot melt extrusion should be listed as prohibited from compounding – but the panel also hopes to see technology advance to change that conclusion.
FDA Endocrinology Division To Be Led By Thanh Hai On Interim Basis; Guettier Leaving For Private Sector
Mary Thanh Hai ran the US agency's division for seven years before moving up in 2013; Guettier’s departure may provide an opportunity for CDER Director Woodcock to start to implement her vision for changes in the Office of New Drugs.
US FDA seeking input on proposed approach to allow device sponsors to seek marketing authorization for a device labeled for use with a drug – even if the drug sponsor does not want to cooperate on the new use.
US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.
Amgen’s argument that continuing the Medicare new technology add-on payment for Blincyto would allow for more data to be collected failed to persuade US CMS.
As the amount of data increases, artificial or augmented intelligence is becoming an increasingly important tool for drug development. More pharma and biotech companies may need to get on board.