For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year's final tally may look very similar to last year's record-low approval total
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CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says
The Center for Drug Evaluation and Research's performance in review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped to 80 percent to 90 percent
Roche’s Actemra Postmarket Safety Plan May Obviate Need For REMS
Roche may have staved off the imposition of a REMS for its rheumatoid arthritis candidate Actemra by proposing a robust pharmacovigilance of its own
For Amgen’s Nplate, No News Is Good News
FDA tells biotech the agency will miss once-postponed July 23 user fee date.