Hii sir, I Wants to get the Syllabus of the Drug Regulatory Affairs – II syllabus of the M pharama Pharmaceutics of the MDU Rohtak

As you Asking for the Syllabus of the Drug Regulatory Affairs – II syllabus of the M pharama Pharmaceutics the Syllabus of the Course is As Follow

DRUG REGULATORY AFFAIRS – II
Unit I
A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to
human drugs, cosmetics and biotechnological products, with special emphasis on:
a. History of drug regulation in USA.
b. Organization and functions of FDA, including historical developments.
c. General definitions.
d. Adulterated & misbranded drugs/cosmetics/biotechnological products.
e. OTC drugs, Orphan drugs, Orange Book and Fast Track Products.
f. General penalties as applicable to drugs, cosmetics and biotechnological
products.


Unit II
A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to
human drugs, cosmetics and biotechnological products, with special emphasis on:
a. General drug approval process.
b. Investigational New Drug application.
c. New Drug Application and BLA.
d. ANDA.
e. SNDA, SUPAC and BACPAC.
f. Post marketing surveillance.
Practicals: ( 6 hrs / week )


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Contact details :
MDU Rohtak
Address: Delhi Road, University Secretariat, Rohtak, Haryana 124001
Phone: 01262 393 596