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16 Cards in this Set
- Front
- Back
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Substitution of an active ingredient in a combo product for another active from apreviously approved product is an example of a change for a ________. |
505(b)(2) |
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Under the FD&C Act a sponsor qualifies for____ exclusivity if (1) the activemoiety has been subject to an approved application (2) the new application mustcontain clinical trial data to support the new application’s approval and (3) the applicant must conduct theclinical trials. |
3 Years |
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Order of highest to lowest: Center, Office, Agency, Department and Division |
Department- Agency-Center-Office-Division |
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Sponsors can send submission request to OOPD on_______with a signed _____. |
physical media with a signed paper cover letter |
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A _______ allows the manufacturer to declare conformance to design controlswithout providing data |
Special 510k |
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A _______ can be submitted for a change that did not adverselyaffect the drug product with a supporting justification as to why. |
Prior Approval Supplement |
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A sponsor may request ODD of a previouslyunapproved drug for a ____for an already marketed drug. |
new orphan indication |
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The _______ requires clinical safety data to be completed in healthy volunteerswhen human clinical efficacy studies areunethical. |
Animal Rule |
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Phase ____ clinicalinvestigations are conducted to determine commonshort term side effects and risks associated with the drug |
Phase 2 |
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Informationamendments to an IND should be submitted no more than every_____ and should include either(1) new tox, chem or other technical info or(2) a report regarding the discontinuance of a clinical investigation |
30 days |
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An IND becomes inactive when there are no subjects entering into clinical studiesfor___ or if all investigations under an IND are on clinical hold for more than______. |
two years or more, one year |
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_______does not have to be completed under GMPs |
Starting Material synthesis |
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A qualityassurance manager _____audit areas of the quality system for which he or she is responsible |
cannot |
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An applicantis required to submit _____information when approval is sought in supplementsinvolving a formulation change, a new condition of use, a new indication, achange in the ROA....... |
Patent |
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Formanufacturing deviation regarding biologics, the reporting period is _____ from discovery |
45 days |
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The finalSPL should be submitted no later than ______from the date of the approvalletter for drugs |
14 days |
