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Once the sponsor has conducted sufficient trials to demonstrate the safety and efficacy of the drug, they submit that information, along with information on manufacturing specifications, drug stability and bioavailablility, and suggested packaging and labeling, as a new drug application (NDA) to the FDA. The NDA is then reviewed by teams of FDA employees, including […]

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One of the plaintiffs in theAmerican Civil Liberties Union’scasechallenging forced separations of asylum seeking families isa woman listed as “Ms. L.” After fleeing political violence in Congo, shepresented herself and her 7 year old daughter at the San Ysidro,Calif.,Port of Entry on Nov. 1, 2017. Arohaine made a connection, and felt a sense of curiosity. […]