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In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
In the U.S. legal system, service of process is the procedure by which a party to a lawsuit gives an appropriate notice of initial legal action to another party (such as a defendant), court, or administrative body in an effort to exercise jurisdiction over that person so as to force that person to respond to the proceeding in a court, body, or other tribunal.
Volumes of the McKinney's annotated version of the CPLR. The New York Civil Practice Law and Rules (CPLR) is chapter 8 of the Consolidated Laws of New York [1] and governs legal procedure in the Unified Court System such as jurisdiction, venue, and pleadings, as well certain areas of substantive law such as the statute of limitations and joint and several liability. [2]
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In the pharmaceutical industry, fill and finish (also referred to as fill finish, fill-finish or fill/finish) is the process of filling vials with vaccine, biological and pharmaceutical Drug Substances (DS) and finishing the process of packaging the medicine for distribution. Many vaccine manufacturers use third parties to fill and finish their ...
The Ready Reserve is a U.S. Department of Defense program which maintains a pool of trained service members that may be recalled to active duty should the need arise. It is composed of service members that are contracted to serve in the Ready Reserve for a specified period of time as a reservist or in active duty status.