US RAC EXAM PREP |ALL WITH DETAILED AND VERIFIED 175 QUESTIONS WITH 100% CORRECT ANSWERS| LATEST 2025 UPDATE| GRADED A+

30-day hold - (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 120-day Safety Report - Amendment to an NDA containing a safety update due 120 days after the NDA is filed. 180-day Exclusivity - Protects an ANDA applicant from competition from subsequent generic versions of the same drug for 180 days.505(b)(2) Application - An application submitted under section 505(b)(2) of the FD&C Act for a drug for which one or more of the investigations relied on bythe applicant for approval of the "application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)). Traditional 510(k) - A premarket notification (PMN) submitted to FDA to demonstrate that the medical device to be marketed is safe and effective or "substantially equivalent" to a legally marketed device. 510(k) refers to the section of the FD&C Act authorizing the submission of the premarket notification. FDA processing time is 90 days. Special 510(k) - For use where device modifications neither affect the intended use nor alter its fundamental scientific technology. FDA processing time is 30 days.Abbreviated 510(k) - A type of 510(k) submission that is supported by conformance with guidance document(s), special controls or standards. FDA processing time is 90 days. 515 Program Initiative - Created to facilitate reclassification action on the remaining pre-amendments Class III 510(k)s. Accelerated Approval - Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical need based on a surrogate endpoint. Action Letter - Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold.ADME - Absorption, Distribution, Metabolism and Excretion