Unapproved Drugs
Some prescription drugs are marketed in the United States without an approved application; these drugs mainly existed before modern requirements for drug approval. The first requirement for drug approval was in 1938; drugs had to demonstrate safety. In 1962, the law was amended to add requirements for efficacy in addition to safety. Regulations require that reports of serious and unexpected adverse events about these prescription drugs must be submitted within the 15-day time frame.
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