US Rac Exam With 100% Questions With Correct Answers
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US Rac
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US Rac
US Rac Exam With 100% Questions With Correct Answers
Kefauver-Harris Amendments - Answer - 1962 amendments to FD&C Act. Require drug manufacturers to prove products safe and effective prior to marketing. Gave FDA control over prescription drug advertising established GMPs and requirement of info...
US Rac Exam With 100% Questions With
Correct Answers
Kefauver-Harris Amendments - Answer - 1962 amendments to FD&C Act. Require drug
manufacturers to prove products safe and effective prior to marketing. Gave FDA
control over prescription drug advertising established GMPs and requirement of
informed consent
Drug Price Competition and Patent Term Restoration Act - Answer - 1984. Hatch-
Waxman Act. Permitted FDA to approve ANDAs for generic drugs when patent of
innovator drug expired. No animal safety or clinical data for establishing safety and
effectiveness required. Bioequivalence, CMC info, labeling, patent certification required.
Same labeling as reference listed drug.
US Code - Answer - Official compilation of codified laws that congress enacts by
subject. 19 titles.
CFR - Answer - Official compilation of regulations. 50 titles. Title 21 food and drugs.
1499 parts in 21 CFR. 300s drugs for human use, 600s biologics, 800s devices, 1270
human tissues.
Drug or biologic not for human use submitted as - Answer - New Animal Drug
Application to center for veterinary medicine or biologics
Suitability Petition - Answer - Petition to submit ANDA for same drug as reference listed
drug with permutation of formulation but same labeling being pursued.
Paragraph I patent certification in ANDA - Answer - Patent has not been filed
Paragraph II patent certification in ANDA - Answer - Patent has expired
Paragraph III patent certification in ANDA - Answer - Patent will expire on certain date
and ANDA won't be marketing prior to that date
Paragraph IV patent certification in ANDA - Answer - Patent is invalid or won't be
infringed by new product
Ctd modules - Answer - 1: administrative 2: summaries 3: quality 4: nonclinical data 5:
clinical data
Fast track designation - Answer - Result of FDAMA 1997. Facilitate development and
expedite review of new drugs intended to treat serious or life threatening conditions that
meet unmet medical need. Can request designation at any point during development.
, FDA will reply in 60 days. Greater probability of priority review of marketing application.
6 months instead of 10 or 8 months instead of 12 if in the program.
Breakthrough therapy designation - Answer - Result of FDASIA 2012. Facilitate
development and expedite review of new medicine intended to treat serious or life
threatening disease and preliminary clinical evidence indicates substantial improvement
over existing therapies on one or more clinically significant endpoints. Request should
be with IND application or IND amendment.
Pre approval Safety update for NDA - Answer - Required to be submitted as an
amendment within 120 days after NDA submission
Most commom uses for 505(b)(2) NDA - Answer - Change in dosage form
(formulation,strength, regimen), change in active ingredient (different salt, acid), new
combination product in which active ingredients have been approved individually,
change from prescription to OTC indication, indication that has not been previously
approved, NCE that is prodrug or metabolite of approved drug. Can be granted 3 years
exclusivity if one or more trials other than BA/BE studies essential to approval was
conducted by applicant. If applicant is original NDA holder those changes are NDA
supplements.
Medical device amendments - Answer - 1976. Redefined medical devices, established
safety and efficacy requirements, established premarket review, established medical
device classification system, created 2 routes to market. Have FDA authority over
promotion of restricted devices
Safe medical device act - Answer - 1990. Extended device incident reporting, required
device tracking for high risk devices, defined substantial equivalence, required that
510(k)s receive clearance before marketing, gave FDA authority to regulate
combination products, defined humanitarian device exemption, gave FDA recall
authority
Humanitarian use device - Answer - Treat or diagnose disease or condition that affects
fewer than 4000 people in US per year. Request for HUD designation of so can submit
Humanitarian device exemption. HDE similar to PMA except exempt from effectiveness
requirements. Can only be used in facilities that have local IRB to supervise clinical
testing of devices.
Design validation - Answer - Conformance to defined user needs and intended uses,
testing of production units under actual or simulated conditions, software validation/ risk
analysis if appropriate
Design transfer - Answer - Translation of device design into production specifications
Determination meeting - Answer - Established by FDAMA 1997. For PMAs or PDPs to
determine type of evidence required to demonstrate safety and effectiveness
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