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  • Drug Approval Process Information

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  • U.S. Food Drug Administration FDA: Drug Device

    Oct 01, 2021 FDA Calendar. PDUFA dates and FDA Panel Review dates are very important catalysts because they are make or break events for biotech stocks. The goal date set by the FDA for announcing its decision on a companys New Drug Application Biologics License ApplicationsBLAsNDA after reviewing the applications is known as the PDUFA date

  • www.rttnews CorpInfo FDACalendar FDA Calendar, FDA Drug Approval, PDUFA Dates RTTNews

    American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDAs Center for Drug Evaluation and Research CDER. The centers best-known job is to evaluate new drugs before they can be sold.CDERs evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely.The centerensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks. Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the companys data and proposed labeling. If this independent and unbiased review establishes that a drugs health benefits outweigh its kn