Session 7: FDA Post-Market Drug Safety Monitoring
Despite the fact that data from clinical trials is crucial for understanding a drug's efficacy and safety, it is difficult to know everything there is to know about a drug's safety at the time of approval. There are restrictions despite the meticulous processes in the drug development process.
As a result, throughout the weeks, months, and sometimes even years that make up a product's existence on the market, the true image of that product's safety actually changes. When FDA receives reports of concerns with prescription and OTC medications, it may decide to add warnings to the dosage or usage instructions or take other action in the case of more serious problems.
In this session You Will find information on:
·Supplemental Application
·INDs for Market Drugs
·Manufacturer Inspections
·Generic Drugs
·Reporting Problems
All accepted abstracts will be published in respective Allied Academies Journals.
Abstracts will be provided with Digital Object Identifier by
