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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 FDA will no longer base decisions on the size of a clinical cancer study alone when considering if it is exempt from investigational new drug (IND) regulations, the agency said in a revised guidance last week.
Biologics manufacturers will have 30 days to formally request a meeting with the FDA to discuss when the agency refuses to consider a biologics manufacturer’s product application, the agency stated in a guidance issued at the beginning of the year.
Drugmakers are letting the FDA know they see some shortcomings in the latest stage of its current Good Manufacturing Practice (cGMP) initiative, in the hopes the agency will incorporate those suggestions in final versions of the draft guidances it issued last fall.
Drugmakers support the move by a major accreditor of continuing medical education (CME) providers to ensure that scientific experts aren’t excluded from CME programs based solely on their connections to pharma firms. However, they would like to see conflict of interest rules applied equally to nonprofit CME sponsors, according to an official at PhRMA.
A major accreditor of continuing medical education (CME) providers has announced that it does not intend to block physicians paid by drug companies from participating in CME events — a possibility that has raised considerable concern among manufacturers over the past 12 months.
The FDA is in the process of updating its 1987 guidance on supporting manufacturing documents for new drug applications to bring the agency's thinking in line with advances in technology and current good manufacturing practices (cGMPs).
Drugmakers who disagree with FDA inspectors on scientific and technical questions during a current Good Manufacturing Practice (cGMP) inspection can now take advantage of a year long dispute resolution pilot program.
If the Center for Biologics Evaluation and Research (CBER) refuses to consider a biologics manufacturer’s product application, the firm has 30 days in which to request a meeting to discuss the reasons for refusal.