Discussion of how adverse events are reported to the fda

Reference no: EM133622744

Pharmacology HST 210

FDA Drug Approval Case Study

Milestones of the Drug Approval Process.
Concept of Informed Consent.
Role of IRB.
Discussion of clinical/non-clinical tests prior to NDA application.
Discussion of how adverse events are reported to the FDA.
Discussion of benefits of meeting with the FDA during development and approval processes.
Discussion of the two (2) different FDA review timelines.
Discussion of the four (4) expedited drug development and review programs and their commonalities.
Discussion of the role of an Advisory Committee in the drug approval process.
Discussion of health risks to be addressed; sponsors and how they mitigate risks; efficacy end point(s) at end of Phase 3 trials; why this end point was selected; and why this diabetes drug will likely not be granted expedited review by the FDA.

For this case study you may use "FDA 2022" for information you wish to cite directly. For your references, you may list the case study as "https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education/drug-approval-case-studies".

Reference no: EM133622744

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