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THE PHARMA REVIEW (MAY – JUNE 2015)

An Overview of New Drug Approval Regulations of United States Food and Drug Administration (USFDA)

Sudheer Moorkoth

Introduction: Regulations and laws safeguard the well-being of the society. Drug regulations safeguard the people with respect to medicines. Drug regulations include drug laws, constitution of drug regulatory agencies and development of regulatory tools such as standards and guidelines, which will help in implementing drug laws. All countries have their own regulatory authorities. USFDA (United States Food and Drug Administration) controls the drug regulations and drug approvals in the US. Regulations of USFDA are considered the “Gold standard” in drug regulations in the world.

 

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