Term
| What is one difference between a device trial and a drug trial? |
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Definition
| Form FDA 1572 is required for a drug clinical trial but not a device clinical trial. |
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Term
| List three regulations that are applicable to both drug and device clinical trials. |
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Definition
| 21 CFR Parts 50, 54, and 56. |
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Term
| List at least two criteria that distinguish the Privacy Rule from the Common Rule. |
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Definition
The Privacy Rule applies to a covered entity's use or disclosure of PHI, for any research purposes regardless of funding or what agency has federal authority over the research.
Under the Common Rule, the scope of the FDA Protection of Human Subject Regulations applies only to research over which FDA has jurisdiction, primarily research involving investigational products. |
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Term
| What are Good Clinical Practices (GCPs)? |
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Definition
| GCPs are international ethical and scientific quality standards used for designing, conducting, monitoring, auditing, analyzing, recording, and reporting clinical trials that involve the participation of human subjects. |
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Term
| What is the clinical trial sponsor's primary responsibility? What is the clinical trial sponsor's most important obligation? |
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Definition
| The primary responsibility is to focus on the clinical study's ethical, scientific, and regulatory obligations. The most important obligation is to ensure and recognize that each study subject's rights, safety, and welfare are protected. |
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Term
FDA interprets its regulatory authority over labeling to include:
a. bottle labels
b. package inserts
c. medication guides
d. promotional materials
e. a, b and c
d. a, b, c and d |
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Definition
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Term
Which of the following is NOT true about Medication Guides?
a. Medication Guides are required to be distributed to a patient each time that the prescription drug product is dispensed.
b. Medication Guides are created for products for which FDA has determined a serious and significant public health concern exists.
c. Medication Guides have standard content and format requirements.
d. Medication Guides must be printed in a minimum 12-point font. |
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Definition
| d. Medication Guides must be printed in a minimum 12-point font. |
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Term
| True or false: PLR format is recommended for any new NDA or labeling supplement in 2009. |
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Definition
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Term
Select the requirement for submission of promotional labeling to FDA that are TRUE.
a. All promotional labeling must be submitted to FDA at the time of initial publication or dissemination.
b. The form FDA-2253 is used for submission of all promotional labeling and must be submitted electronically.
c. Submissions requirement are the same for drugs, biologics, and medical devices.
d. It is not required to submit direct-to-consumer television advertising first for advisory comment.
e. Products approved under accelerated approval conditions must submit drafts of promotional labeling to FDA for advisory comment at least 30 days prior to dissemination. |
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Definition
a. All promotional labeling must be submitted to FDA at the time of initial publication or dissemination.
d. It is not required to submit direct-to-consumer television advertising first for advisory comment.
e. Products approved under accelerated approval conditions must submit drafts of promotional labeling to FDA for advisory comment at least 30 days prior to dissemination. |
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Term
| True or false: The Brief Summary differs from the full prescribing information in that it is included with print advertisements, whereas the full prescribing information must accompany all promotional labeling. |
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Definition
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Term
The two exceptions to prohibition on pre-approval promotion are "Coming Soon" and "Disease Awareness" or "Institutional promotion" campaigns. When is the only time it is permitted to use both forms interchangeably?
a. It is permitted to use a "Coming Soon" campaign only if followed by a "Disease Awareness" campaign.
b. It is permitted to use a "Disease Awareness" campaign only if followed by a "Coming Soon" campaign.
c. It is permitted to use a "Coming Soon" campaign or a "Disease Awareness" campaign, but companies may not begin with one campaign and then switch to the other.
d. Never. Pre-approval promotion of any kind is strictly prohibited. |
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Definition
| c. It is permitted to use a "Coming Soon" campaign or a "Disease Awareness" campaign, but companies may not begin with one campaign and then switch to the other. |
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Term
Which of the following ways does the FDA become aware of violative advertising?
a. Routine review of materials submitted under FDA Form 2253
b. As part of its monitoring and surveillance program
c. Complaints from competitors, physicians, and consumers
d. By observing conversations of sales reps
e. a, b and c
f. a, b, c and d |
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Definition
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Term
| True or false: An IVD can be either a device or a biologic. |
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Definition
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Term
| True or false: "IVDMIA" stands for In Vitro Diagnostic Multivariate Index Analyte. |
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Definition
| False: "IVDMIA" stands for In Vitro Diagnostic Multivariate Index Assay. |
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Term
| True or false: A Class III novel analyte will be referred by FDA to an advisory panel before approval and will require prospective clinical data. |
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Definition
| False. A novel analyte is likely to be referred to an advisory panel, but panel review is not mandatory. While some PMAs require prospective clinical data, FDA accepts the use of remnant or banked specimens under certain conditions and for certain types of products. |
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Term
For a device to be cleared under a traditional 510(k), a product sponsor must prove to FDA that:
a. the new device has the same intended uses as a previously cleared device
b. the new device is substantially equivalent to a previously cleared device
c. the new device improves on the technology of a previously cleared device |
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Definition
| b. the new device is substantially equivalent to a previously cleared device |
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Term
RUO and IOU products
a. cannot be marketed with diagnostic claims
b. are subject to QSR requirements
c. are considered safe and effective for IVD use |
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Definition
| a. cannot be marketed with diagnostic claims |
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Term
Indicate what records need to be reviewed to make an HCT/P donor eligibility determinations.
a. Report of physical examination
b. Communicable disease test results
c. Medical history interview
d. Available medical records
e. All of the above |
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Definition
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Term
| True or false: A human tissue has been more than minimally manipulated and will be used for a non-homologous use. This tissue can be distributed without pre-market approval. |
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Definition
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Term
| True or false: A patient received a human bone transplant and developed a severe bacterial infection that resulted in removal of the transplant. The physician reports this reaction to the establishment that processed and released the bone for transplantation. The processing establishment has the report this adverse reaction to FDA. |
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Definition
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Term
| True or false: A tissue processor must be licensed in order to distributed tissues regulated under the PHS Act, Section 361 and 21 CFR Part 1271. |
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Definition
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Term
| True or false: Donor eligibility requirements are a subset of CGTPs. |
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Definition
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Term
| True or false: The regulations under 21 CFR Part 1270 and 1271 focus on safety, efficacy and potency of human cell and tissue products. |
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Definition
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Term
| True or false: If a physician is permitted to use a drug or device for an off-label indication, my company may provide him with any literature that he requires to assist him in this use, without any fear of sanction. |
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Definition
| False. Companies are restricted to promoting a product for its on-label uses, even in contexts where the product is used off-label. However, if that physician has requested scientific literature related to the off-label use of the product, you may be able to safely provide it to him pursuant to a properly structured literature dissemination program. |
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Term
| True or false: There is no problem with sponsoring travel costs to a national conference for healthcare plan technology approval committee personnel. |
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Definition
| False. This type of subsidy may be prohibited under certain state laws, and would likely raise at least the concern that it might be an improper inducement of a sort that is prohibited under the Anti-Kickback Statute. |
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Term
| True or false: Medical device companies are exempt from regulation under state laws related to sales and marketing; these laws only affect pharmaceutical manufacturers. |
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Definition
| False. Many of the newer iterations of these laws apply to both device and pharmaceutical companies. |
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Term
| True or false: It is critical that all coding materials be reviewed by competent coders. |
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Definition
| True. Coding is complex and providing mistaken coding advice can lead to substantial legal exposure. |
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Term
| True or false: So long as our company operates in an ethical manner, there is no reason to adopt a formal compliance program. |
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Definition
| False. There are many reasons why your company should adopt a formal, written compliance program, For example, the laws related to fraud, waste and abuse are complex and sometimes counter-intuitive. Operating without specific guidance can put you at risk of violating them. In addition, some states now require that companies adopt written compliance programs. |
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