Exam (elaborations)

RAC Chapter 3 Test Questions and Answers All Correct

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rac
rac chapter 3 test
fast track designation
rac chapter 3 test questions and answers

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Course RAC

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RAC Chapter 3 Test Questions and
Answers All Correct

Fast Track Designation - Answer- 21 CFR 312 defines a serious disease as ' a disease
or condition associated with morbidity that has substantial impact on day-to-day
functioning. Short-lived and self-limiting morbidity wii usually not be sufficient, but the
morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or
condition is serious is a matter of clinical judgement, based on its impact on such
factors as survival, day-to-day functioning or the likelihood that the disease if left
untreated will progress from a less sever condition to a more serious one' .
'Unmet medical need ' is defined as ' a condition whose treatment or diagnosis is not
addressed adequately by available therapy. An unmet medical need includes an
immediate need for a defined population or longer-term need for society'
The sponsor can request fast track designation at any point. FDA wii provide response
within 60 days, if data no longer support fast track, FDA will reclassified the product.
FTD Benefits: eligibility for heightened interaction with FDA , greater probability of
marketing application priority review (6 months vs 10 months) , submission of complete
CTD modules as individual ' reviewable units'

Breakthrough Therapy Designation - Answer- FDASIA (food and drug safety and
innovation act )
BTD goal is to expedite development and review of a potential new medicine if '
intended. alone or in combination with one or more other drugs, to treat a serous or life-
threatening disease or condition, and pre,iminaru clinical evidence indicates that the
drug may demonstrate substantial improvement over existing therapies on one or more
clinically significant endpoints such as substantial treatment effects observed early in
clinical development'
Request with or as an amendment to IND, FDA responds within 60 days.

GAIN Act and QIDP Designation - Answer- antibacterial and anti-fungal drugs for
human use treating infections ;
' an antibacterial or anti-fungal resistant pathogen, including novel or emerging
infectious pathogens, or qualifying pathogens' . 5 years of exclusivity

ICH - Answer- objectives: conserving human, animal and material resources and
eliminating unnecessary delays in global development and availability of new medicines
while safe-guarding quality, safety , efficacy and protecting public health.

EU, JAPAN, US

CTD Common Technical Document - Answer- - Module 1 ( not CTD) :Regional Admin
Information contains FDA forms, draft labeling, Risk Evaluation and Mitigation

, Strategies) , FDA correspondence, patient info, IB if IND. Module 2 : Quality Overall
Summary , Module 3 :Quality Module 4 : Nonclinical Study Reports ( overview and
summary) Module 5 : Clinical study reports ( overview and summary)

MedDRA - Answer- terminology dictionary developed by ICH to support medical
information classification, retrieval, presentation and communication throughout the
drug and medical device regulatory cycle.

Initial IND and IND Amendments 21 CFR 312.23 - Answer- IND final number is the
same number without P;
the sponsor can start study if not receive from FDA within 30 days since submission and
receipt;
reviewing group: a medical reviewer, pharmacology/toxicology reviewer, a CMC
reviewer or may a statistician or clinical pharmacologist.
for NCE, IND is a major milestone because it moves a drug from in vitro and animal
testing into human clinical trial;
3 copies are required . 1572 Form or CTD format can be used for initial submission,
eCTD benefit eventual marketing application since files can be updated progressively

IND Safety Reporting 21 CFR 312.38 - Answer- IF SAE, need submit Safety report to
FDA
the day the sponsor is notified of the SAW is considered Day 1 -- Guidance for Industry
and Investigators- Safety Reporting Requirement for INDs and BA/BE Studies

IND Annual Reports - Answer- within 60 days of the anniversary date ( the date the IND
went into effect), focus on clinical safety signals or any new nonclinical safety findings
and coming year's plan.- guidance of E2F Development Safety Update Report

NIH register on www. clinicaltrials.gov

NDA 505(b)(1) 21CFR 314 - Answer- Pre- NDA Meeting held usually no later than three
months prior to the target NDA filing date.

Labeling : Package Insert - Answer- Label is a main NDA component , labeling must be
submitted to FDA in structured product label format ( SPL) within an XML (Extensible
Markup Language) . label format must be confirmed in either the Pre-NDA meeting or
with the FDA project manager prior to filing the NDA. sponsor need to submit a final
copy of label to NDA in SPL format following PLR( Physician labeling rule) rule which
requires three parts: highlights( one page) , contents and full prescribing information.

Electronic Submission - Answer- effective 5 May 2017, all NDAs, ANDAs, BLAs and
master files must be submitted in eCTD format, after 5 May 2018 all commercial INDs
must be submitted in ECTD format.

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RAC Chapter 3 Test Questions and Answers All Correct

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