CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs

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