US RAC Exam Prep Questions And Answers All Correct Graded A+.

30-day hold - correct answer (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 - correct answer Amendment to an NDA containing a safety update due 120 days after the NDA is filed. 180-day Exclusivity - correct answer Protects an ANDA applicant from competition from subsequent generic versions of the same drug for 180 days. 505(b)(2) Application - correct answer 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 by the 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) - correct answer 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) - correct answer 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) - correct answer 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 - correct answer Created to facilitate reclassification action on the remaining pre-amendments Class III 510(k)s. Accelerated Approval - correct answer Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical need based on a surrogate endpoint. Action Letter - correct answer Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold. ADME - correct answer Absorption, Distribution, Metabolism and Excretion Adulterated - correct answer Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; or containing an unsafe color additive; or does not meet the requirements of an official compendium (FD&C Act, SEC. 501 [351]) Advisory Committee - correct answer Committees and panels used by FDA to obtain independent expert advice on scientific, technical and policy matters. ANDA - correct answer Abbreviated New Drug Application. Used for generic drugs. Found in 21 CFR 314.92 and 505(j) of the FD&C Act. Are not required to include animal safety and clinical data to demonstrate safety and efficacy, but for oral dosages forms must scientifically demonstrate that the drug is bioequivalent to the Reference Listed Drug (RLD). CMC (Chemistry, Manufacturing and Controls) is required. Annual Report - correct answer An annual periodic report or progress report that must be submitted to FDA. Depending on the type of application for which the report is submitted, it may include new safety, efficacy and labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical laboratory studies; and completed unpublished clinical trials Approved - correct answer FDA designation given to drugs, biologics and medical devices that have been granted marketing approval Banned Device - correct answer Device presenting a substantial deception, unreasonable risk or injury or illness, or unreasonable direct substantial danger to public health. BIMO - correct answer Bioresearch Monitoring Program Bioequivalence - correct answer The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Biologic - correct answer A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment or cure of disease or condition of human beings. Biosimilar - correct answer Under the BPCI Act (Biologics Price Competition and Innovation Act of 2009), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already approved biological product. BLA - correct answer Biologics License Application CBE-30 - correct answer Changes Being Effected in 30 days. A submission to an approved application reporting changes the FDA has identified as having moderate potential to adversely affect drug product identity, strength, quality, purity and potency. The supplement must be received by FDA at least 30 days before product distribution. CBER - correct answer Center for Biologics Evaluation and Research CDER - correct answer Center for Drug Evaluation and Research CDRH - correct answer Center for Devices and Radiological Health Consent Form (CF or ICF) - correct answer Document used to inform a potential subject of the risks and benefits of a clinical trial per the Declaration of Helsinki. Certificate to Foreign Government (CFG) - correct answer Required by certain countries to prove that an exported product can be legally marketed in the US. CFR - correct answer Code of Federal Regulations Class I Device - correct answer Low-risk device requiring general controls to ensure safety and effectiveness. Class II Device - correct answer Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials. Class III Device - correct answer Requires general controls, special controls and premarket approval (PMA); includes devices that are life-sustaining, life-supporting or pose significant potential for risk to patient, or are not substantially equivalent to Class I or Class II devices. PMAs almost always require clinical trials. Clearance - correct answer Devices that receive marketing permission through the 510(k) process based on demonstrating substantial equivalence to a pre-amendment device or another device reviewed under section 510(k) of the FD&C Act. Clinical Hold - correct answer FDA order to delay proposed clinical investigation or suspend an ongoing investigation. Combination Product - correct answer Defined in 21 CFR 3.2(e) as a combination of two or more different types of regulated products, i.e.: - a drug and a device - a device and a biological product - a drug and a biological product - a drug, a device and a biological product Commercial Distribution - correct answer Any distribution of a device intended for human use, which is offered for sale but does not include: internal or interplant transfer within the same parent, subsidiary or affiliate company any device with an approved exemption for