Seligman joined FDA in 2001 as the Director of the CDER
Office of Pharmacoepidemiology and Statistical Science (OPaSS).
Russell Wesdyk, OPS Scientific Coordinator, CDER
, will give the FDA's viewpoint.
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.
We are thankful to CDER
, the Drug Shortage Team, and OPQ for working so diligently to help resolve these issues.
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.
Drug evaluation and approval for marketing is the primary activity of the CDER
During the term of the license, CDER
will use I2E to mine published literature and drug product labels to answer questions relating to a range of biomedical topics, including drug toxicity mechanisms and disease processes.
work at different floors at CDER
of AIIMS A/R and M/O CDER
La production de l'electricite a partir des energies renouvelables a enregistre une croissance de 8%, selon le Pr Noureddine Yassaa, directeur de l'EPST Centre de developpement des energies renouvelables (CDER
) dans une contribution publiee recemment dans le bulletin du CDER
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.
The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER