67ddb5bf-c739-4c5e-81b7-46fce5b94a05.pdf

Total Questions: 206 Latest Version: 6.0 Question: 1 Serious enforcement letter issued by FDA notifying a regulated entity of violative activity; requires immediate action within 15 days. A. True B. False Answer: A Question: 2 Device Master Record. Compilation of records containing a finished device...

Total Questions: 206 Latest Version: 6.0 Question: 1 Serious enforcement letter issued by FDA notifying a regulated entity of violative activity; requires immediate action within 15 days. A. True B. False Answer: A Question: 2 Device Master Record. Compilation of records containing a finished device's procedures and specifications. A. True B. False Answer: B Question: 3 Adverse event monitoring and reporting. A. Common Rule B. Phase Ii C. Pharmacovigilance D. Pharmacoepidemiology Answer: C Question: 4 Visit us at A meeting needed to help an otherwise stalled product development program proceed. Scheduled within 30 days of FDA receipt of a written meeting request. Examples include: - Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level - Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed - Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment A. Type A Meeting B. Agreement Meeting C. Class Ii Device D. Clinical Hold Answer: A Question: 5 Health Insurance Portability and Accountability Act of 1996, also known as the Privacy Rule, established the minimum federal requirements for protecting the privacy of individually identifiable health information. A. HIPAA B. USP C. FOIA D. OBRA Answer: A Question: 6 Good Clinical Practice. Regulations and requirements with which clinical studies must comply. These regulations apply to manufacturers, sponsors, clinical investigators and industrial reivew boards. A. GMP B. CPR C. GLP D. GCP Answer: D Visit us at Question: 7 Financial Disclosure by Clinical Investigators A. 21 CFR 54 B. 21 Cfr 49 C. 21 Cfr 207 D. 21 Cfr 312 Answer: A Question: 8 A report filed with FDA within three working days of obtaining information on any distributed drug product that has contamination, significant chemical or physical change, deterioration, batch failure or labeling causing mistaken identity. A. Phase Ii B. Cdrh C. NDA Field Alert D. Bimo Answer: A Question: 9 Required by certain countries to prove that an exported product can be legally marketed in the US. A. Orphan drug B. Primary mode Of Action (pmoa) C. Transitional device D. Certificate to Foreign Government (CFG) Answer: D Question: 10 Premarket notification procedures A. 105 Cfr 807 Subpart E Visit us at B. 21 Cfr 812 Subpart E C. 21 Cfr 312 Subpart E D. 21 CFR 807 Subpart E Answer: D Question: 11 Documents published by the FDA to provide currently interpretation of regulations. A. Component B. Wisdom C. Guidance D. Rules Answer: C Question: 12 Reference Listed Drug. Drug product listed in the Approved Drug Products with Therapeutic Equivalence Evaluations Book (also know as the Orange Book). A. RLD B. LLD C. COPD D. LAX Answer: A Question: 13 Drug Price Competition and Patent Term Restoration Act of 1984. Established a process for the approval of drugs based on comparison to already approved product and provided for exclusive marketing status for a period of time based on the length of the approval process for new drugs or the patent status of the branded drug for generics. It authorized Abbreviated New Drug Applications (ANDAs) for generic drugs and specifically provided that FDA could require only bioavailability studies for ANDAs. A. Emergency Use Ind B. Durham-humphrey Act C. Drug Listing Act D. Hatch-Waxman Act Visit us at Answer: D Question: 14 Human Cells, Tissues, and Cellular and Tissue-Based Products A. HCT/P B. Hcv C. Cjd D. Wnv Answer: A Question: 15 Drugs for Animal Use A. 21 cfr 207 B. 21 Cfr parts 300s C. 21 CFR parts 500s D. usp Answer: C Question: 16 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices A. 21 CFR 807 B. 21 Cfr 797 C. 21 Cfr 312 D. 21 Cfr 812 Answer: A Question: 17 Human Cells, Tissues and Tissue-Based Products A. 21 CFR 1271 Visit us at B. 21 Cfr 207 C. 21 Cfr 820 D. 21 Cfr 312 Answer: A Question: 18 Investigation New Drug (application) A. CDER B. BLA C. IND D. NDA Answer: C Question: 19 Committees and panels used by FDA to obtain independent expert advice on scientific, technical and policy matters. A. Advisory Committee B. The Research Center C. Real Estate Broker Lawyer Committee D. Administrator Answer: A Question: 20 Manufacturer and User Facility Device Experience database. Contains reports of adverse events involving medical devices. A. YOHAN B. MAUDE C. DAISY D. MEDWATCH Answer: A Visit us at Question: 21 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)). A. 505(b)(2) Application B. cfr C. special 510(k) D. transitional Device Answer: A Question: 22 A set of research ethics principles for human experimentation that was created as a result of atrocities involving medical experimentation on humans during World War II. A. Nuremberg Code of 1947 B. Nuremberg Code of 2047 C. National research act of 1974 D. Nuremberg Code of 1937 Answer: A Question: 23 Nonsignificant Risk A. SVT B. NSR C. PACS D. NSS Answer: B Question: 24 Visit us at Humanitarian Device Exemption. Humanitarian Use Devices are devices for use in the treatment or diagnosis of diseases or conditions affecting few than 4,000 patients in the US each year. A. Emergency Use Ind B. Ivd C. Qsr D. HDE and HUDs Answer: D Question: 25 Good Laboratory Practice. Regulations governing the conduct of nonclincal laboratory studies that support or are intended to support applications for research or marketing applications. A. GLP B. GMP C. GCP D. CPR Answer: A Question: 26 An investigation device that: - is intended as an implant - is represented to be for use in supporting or sustaining human life - is for a use of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the subject's health, safety or welfare A. Clearance B. Significant Risk Device C. Emergency Use Ind D. Class Ii Device Answer: B Question: 27 An ingredient contained in a drug formulation that is not a medicinally active constituent. Visit us at A. Solvent B. Misbranded C. Component D. Excipient Answer: D Question: 28 Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical need based on a surrogate endpoint. A. Fast Track B. Surrogate Endpoint C. Accelerated Approval D. Priority Review Answer: C Question: 29 Center for Drug Evaluation and Research A. CDER B. CBER C. OCP D. CDRH Answer: A Question: 30 A format for a summary of a drug development program described in terms of labeling concepts. A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. A. Fd&c Act Of 1938 B. Warning letter (wl) C. Recall D. Target Product Profile (TPP) Visit us at Answer: D Question: 31 New Drug Application A. NDA B. ADME C. IND D. BLA Answer: A Question: 32 Accelerated approval of new drugs for serious or life-threatening illnesses A. 21 Cfr 628 Subpart H B. 21 Cfr 312 Subpart E C. 10 Cfr 314 Subpart H D. 21 CFR 314 Subpart H Answer: D Question: 33 Food and Drug Administration Safety and Innovation Act of 2012. Gives FDA authority to collect user fees from industry to fund review of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development. This is the 5th authorization of PDUFA (aka 'PDUFA V') and the 3rd authorization of MDUFA (aka 'MDUFA III'). FDASIA helps to ensure FDA has consistent funding for Fiscal 2013-2017 to help maintain a predictable and efficient review process. A. PPACA B. LEADER C. FDASIA D. DSCSA Answer: C Visit us at