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WorksheetsCLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs
Total questions: 30
Worksheet time: 30mins
Select the responsibility/s of Regulatory Affairs personnel
To analyze the content of the active ingredient in the formulation
Work with federal, state and local governing agencies to get the approval for drug
To undertake stability studies of the drug products
To supervise the production of the formulation
What Are The Goals Of Regulatory Affairs Professionals?
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Above all
What Are The Roles Of Regulatory Affairs Professionals?
Preparation of organized and scientifically valid NDA, ANDA, IND, DMF submissions.
Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws.
Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans.
Above all
IND is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
True
False
BCS classification for Class III drugs is
High solubility high permeability
Low solubility high permeability
High solubility low permeability
Low solubility Low permeability
Animal studies, clinical trials, bioavailability studies are part of which application process
IND
NDA
ANDA
BLA
Type II DMF deals with
Packaging materials
Manufacturing Site
Drug substance
Excipients
It is an application for the approval of Generic Drugs
NDA
BLA
IND
ANDA
Important facts regarding DMFs :
It is submitted to FDA to provide confidential information
Its submission is not required by law or regulations
It is neither approved nor disapproved
Above all
On average, it takes ____________ years to do the discovery research and testing to bring a new drug to the market.
6-9
9-12
12-15
15-18
What is the major trigger of clinical study delays?
Budget concerns
FDA hold-ups
Recruitment problems
Safety/toxicity issues
What is the term for the process that is used to prove that a drug is safe and effective in treating specific conditions in certain patient populations?
Drug discovery
Preclinical development
The patent process
Clinical development
Which department is not primarily involved with the creation of the package insert?
Marketing
Clinical Development
Business Development
Regulatory Affairs
Most pharma companies have a regulatory affairs function that acts as their liaison between the company and the FDA during the clinical trial process.
True
False
When does a company seek permission to market a product in the US?
Following the completion of Phase 1
Following the completion of Phase 2
Following the completion of Phase 3
Following the completion of Phase 4
IND' means
Investigational novel drug application
Investigational new dose application
Investigational new drug application
None
The requirements for the format and content of the IND application, as well as the requirements governing the use of the IND, are provided in ........................
21 CFR, 315
21 CFR, 316
21 CFR, 314
21 CFR, 312
In USA, applicant can start the Phase 1 clinical trials without approval of IND application.
True
False
Form FDA 1571 is part of IND application.
True
False
IND application do not contain 'Investigator's brochure'
True
False
Chemistry, manufacturing, and control data is not required to submit along with the IND application.
True
False
Pharmacology and toxicology data is also part of IND application.
True
False
Institutional review board data information is not required while submitting the IND application.
True
False
'NDA' means:
New dose application
New drug applicant
New drug application
None
In USA, NDA has to be submitted using ............
eCTD
CTD
Paper
NeeS
NDA 'Standard review' time ...............
12 months
6 months
3 months
8 months
NDA 'Priority review' time ...............
12 months
6 months
3 months
8 months
eCTD submission gateway for NDA ...............
web client
e-Submission gateway and the web client
Electronic Submissions Gateway
None
NDA Application fee for single application Aprox. ................
$ 3,421,495
$ 2,421,495
$ 1,421,495
$ 4,421,495
NDA is approved only by USFDA
True
False
