Center for Drug Evaluation and Research

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Center for Drug Evaluation and Research

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CDER

A division of the U.S. Food and Drug Administration that reviews and oversees the manufacture of pharmaceuticals distributed to U.S. citizens and provides clinical information about the uses and hazards of drugs. Website: www.fda.gov/cder/
References in periodicals archive ?
Un hommage a ete rendu au Dr Nachida Kesbadji-Merzouk, ex-directrice de l'Unite de developpement des equipements solaires, affiliee au CDER, pour [beaucoup moins que] son devouement et investissement sans faille au service des energies renouvelables, depuis 1986 [beaucoup plus grand que].
along with "new and innovative uses" of drugs that are already available, blogged CDER director Dr.
CDER then issues a WL, which cautions the manufacturer about the significant regulatory violations and formally establishes prior notice.
If a company has questions regarding whether a specific change requires a supplement or may be included in the annual report, CDER directs them to the appropriate review division in the Office of New Drug Quality Assessment (ONDQA), Office of Generic Drugs (OGD), or New Drug Microbiology Staff (OPS-NDMS).
The site, currently hosted on the CDER's home page, will also allow visitors to identify therapeutically equivalent drugs for prescription medicines and alternative OTC drugs, as well as learn if there are generic versions of brand name medications.
Drug evaluation and approval for marketing is the primary activity of the CDER. While it is the drug sponsor's obligation to do the research to identify and test the clinical safety and efficacy of a new compound, it is CDER's obligation to evaluate the drug and determine whether the benefits of the drug outweigh its risks.
This agreement is with the Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN).
Les chercheurs du centre de developpement des energies renouvelables (CDER) ont celebre jeudi le 30eme anniversaire de la creation de leur structure a l'unite de developpement des equipements solaires (UDES) de Bou-Ismail, dans la wilaya de Tipasa.
"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," commented Richard Pazdur, director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research (CDER).
The FDA's supervisory agency, the Center for Drug Evaluation Research (CDER), is directly responsible for the Finished Pharmaceuticals sector, which includes over -the-counter drugs (U.S.
In cooperation with the FDA CDER Drug Shortage Team, ChiRhoClin is permitted to market the current batch of ChiRhoStim(r) until its new manufacturing site is operational by the beginning of 2013.
Within the FDA, the biggest number of jobs will go to the Center for Drug Evaluation and Research (CDER), according to the AP.