Sinónimos & Anagramas | Palabra Inglés CDER

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Ejemplos de uso de CDER en una oración

• After there is adequate completion of research and development phases by the drug companies, they send a New Drug Application (NDA) or a Biologics License Application (BLA) for approval to the FDA's Center for Drug Evaluation and Research (CDER) and the proposed scientific evidence for use in an intended population is evaluated by a team of physicians, statisticians, chemists, pharmacologists, and other scientists.
• In 1987, under Commissioner Frank Young, CDER and the Center for Biologics Evaluation and Research (CBER) were split into their present form.
• The committee, consisting of members from academic and clinical oncology biostatistics, the general public, and the pharmaceutical industry, makes non-binding recommendations to both the CDER and CBER divisions of the FDA about the advisability of approving new medications to treat cancer.
• The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities.
• The research institutes for renewable sources of the governments of Morocco (CDER), Algeria (NEAL), Libya (CSES), Egypt (NREA), Jordan (NERC) and Yemen (Universities of Sana'a and Aden) as well as the German Aerospace Center (DLR) made significant contributions towards the development of the DESERTEC Concept.
• In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration.
• The HL7 standard will be implemented first at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in late 2011, before being rolled out to the other centers using a yet-to-be-determined schedule.
• The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by the FDA.
• The committee, consisting of members from academic and clinical dermatology, ophthalmology, biostatistics, the general public, and the pharmaceutical industry, makes non-binding recommendations to both the CDER and CBER divisions of the FDA about the advisability of approving new medications to treat dermatologic and ophthalmic conditions.

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