The regulation of new drugs in United States is based on NDA (New Drug Application).Its mission is to ensure that patients
get access to good medicines without unnecessary delay,help pharmaceutical companies to get their medicines to the market
at the right time, help regulatory agencies to approve the right medicines much faster. .NDA provides information to FDA (Food
and Drug Adminstration) reviewers if the drug is safe and effective,the benefits of the drug outweighs the risks,drugs proposed
labelling is appropriate,the methods and controls used in manufacturing drug to maintain drugs quality are adequate to preserve
its identity,strength,quality and purity.Documentation also demands drugs whole story,what happened during clinical trials,how
drug behaves in the body,how it is manufactured,processed and packaged.ANDA (Abbreviated New Drug Application) do not
require preclinical (animal) and clinical (human) studies to establish safety and effectiveness.It should scientifically demonstrate
that their product is pharmaceutically equivalent bio-equivalent with the innovator drug and thus fully interchangeable with
the innovator drug.Once approved the applicant can manufacture and market the generic product as safe,effective and low cost
alternative.The generic version must deliver the same amount of active ingredients into a patients blood stream in the same time
as the innovator drug.
I am presently doing my post graduation(M.Pharm) in the branch of Pharmaceuical Analysis and Quality Assurance at Andhra University College of
Pharmaceutical Sciences.Did my graduation(B.Pharm) at Shri Venkateswara College of Pharmacy, Etcherla.
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