Tag:
CDER
Latest Headlines
Latest Headlines
FDA: Product quality issues fuel rise in drug shortages
"A very large number of quality product issues" is what Valerie Jensen, associate director for FDA's drug shortage program ( CDER ), cites as the major cause of the 178 shortages counted by the
FDA tests nano waters, reorganizes CDER
Sidling up to the complexities of nanotechnology in drug bioavailability, formulation and delivery, FDA Commissioner Margaret Hamburg notes that a recently issued draft guidance avoids an actual
Senator calls for outsourcing probe at FDA
A new senator is leaping into the pharma fray. Sen. Sherrod Brown, an Ohio Democrat, is calling on the FDA to evaluate its oversight of outsourcing practices. In a letter to the agency, Brown cites a
FDA to piggyback on insurers' databases
Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug
On-deadline drug data disputed
Yesterday, a study that seemed to show on-deadline drug approvals led to more safety problems. Today, the
FDA chief: Woodcock is a 'change agent'
No, says Andrew von Eschenbach, it's not business-as-usual at the FDA. A thousand times no. The agency commish got peeved during an appearance at the American Enterprise Institute when someone
FDA taps new-yet-old drug chief
As the ink was still drying  on the new drug-safety bill, FDA shuffled its management, bringing back Janet Woodcock as director of the
