[nilesh]

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Hi I would like to have the information and also the details for Development and Regulation of OTC (Non-prescription) Drug Products?

[prince karak]

Over-the-counter (OTC) medications are produced under the OTC Monograph Process or through the New Drug Application (NDA) Process. FDA's audit of OTC medications is principally dealt with by the Center for Drug Evaluation's Office of Drug Evaluation IV.

OTC Drugs Developed Through the NDA Process

A support trying to market its item OTC, either as another NDA or as a change from a solution item, applies to the Division of Nonprescription Drug Products (DNDP) in the Office of Drug Evaluation IV.

DNDP will direct medication advancement, including the survey and administrative activity on Investigational New Drugs (INDs), and may acquire contribution from the particular topic audit division (SSMRD) amid the improvement procedure. After a support presents a NDA, DNDP surveys the purchaser thinks about, the post showcasing wellbeing information, the OTC marking, and any administrative issues.

The SSMRD teams up with DNDP (see MaPP 6020.50) and ordinarily gives audit of the viability and security information identified with controlled clinical trials. Extra information is gotten as required from different trains outside of DNDP, including clinical pharmacology, measurements, and science.

Differences: NDA Process and OTC Monograph Process