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Representatives of drug manufacturers who were acting members on the Center for Drug Evaluation and Research's (CDER's) advisory committees will be made permanent, but still nonvoting, within three to six months, according to Igor Cerny, acting director of the CDER's advisory committee group.
Acting industry representatives serving on the Center for Drug Evaluation and Research's (CDER's) advisory committees may become permanent in the next three to six months when the center plans to make those positions permanent but still nonvoting, Igor Cerny, acting director of the CDER's advisory committee group, told DID.
The address for the Central Documents Room for filing Drug Master File (DMF) updates has changed, according to the Center for Drug Evaluation and Research.
FDA hopes to continue increasing the number of drug approvals while speeding up review times this year using a three-pronged strategy it adopted last year, the agency announced Jan. 15.
Future guidances from the Center for Drug Evaluation and Research (CDER) will focus on clinical/medical guidances and procedural issues in 2004, shifting from last year’s heavy focus on International Conference on Harmonisation (ICH) initiatives, the agency stated in an agenda released Jan. 21.
The FDA is going to shift its focus this year from extensive guidances on International Conference on Harmonisation (ICH) initiatives to clinical/medical guidances and procedural issues, according to an agenda released yesterday.
The Center for Drug Evaluation and Research (CDER) has revised its address for the Central Documents Room for filing Drug Master File (DMF) updates, the center announced recently.
Concerns that limited funds in the Center for Drug Evaluation and Research’s (CDER’s) budget could pose problems with that center’s expanded mission in counterbioterrorism, new product applications, and postmarket surveillance were independently confirmed by a recently released Tufts University study.
A Tufts University study has confirmed suggestions by the FDA that limited funds in the Center for Drug Evaluation and Research’s (CDER’s) budget might pose a serious threat to counterbioterrorism efforts, the review of complex new product applications and increased postmarket surveillance activities.