InterrogAaAaAeA@ sur le rAaAaAeA le du CDER
dans cette politique, M.
launched the DataFit project in 2011 with the goal of enabling its reviewers to rapidly assess whether submitted data was "fit for use" - to make the submission process more efficient and help get important new drugs to market safely and more quickly.
Category 3 lists the most serious CDER
enforcement activities: consent decrees to halt manufacturing with full plant closure.
The company and the CDER
have filed their joint clinical trials proposal for review by the FDA Commissioner.
I don't think she's the kind of CDER
director we need right now," Dr.
Despite that perception, because CDER
is not as familiar with biologics as CBER, it could take a lot longer for some of these drugs to be approved,'' Ghodsian said.
may meet with sponsors during the review process to discuss scientific, medical, and procedural issues and give the sponsors an opportunity to correct deficiencies.
est un partenaire actif dans le programme national de developpement des energies renouvelables, a indique a l'APS son directeur, Noureddine Yassaa.
These numbers include both new molecular entities (NMEs), submitted to CDER
in New Drug Applications (NDAs) and new therapeutic biologies submitted to CDER
in Biologies License Applications (BLAs).
By reviewing the data in this case study, the research is establishing some anecdotal evidence about CDER
performance and its use of quality assurance techniques.
assesses new medications and monitors the safety of drugs on the market.
The monitoring board said it came away from meetings with CDER
staff and management "with a deep concern about CDER
's organizational health.