Policy, Regulatory and Research

Stages of Drug Development: 1 IND Animal tests 2 IND Review by FDA and local IRB Animal tests 3 Phase 1 Healthy volunteers, tests safety 4 Phase 2 Sick volunteers, tests effectiveness 5 Phase 3 Larger scale, test effectiveness and adverse effects 6 Post-marketing Review 7 NDA application   8 FDA Review and decision   […]

Expedited IRB Review: Minimal or no risk Involve data, documents, specimens etc that have been collected for non-research purposes. IRB Exempt: Research in established or commonly accepted educational settings Use of educational tests where subjects cannot be IDed The use of texts and surveys if the subject is a public official under FOIA. Collecting or […]

Medication Error Definitions: Mild: enhanced monitoring, no harm Moderate: active treatment required, enhanced monitoring, but no lasting harm Severe: patient harm that requires enhanced treatment and increased patient stay FDA’s Adverse Event Reporting System (FAERS): FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that […]

This section is tricky.  I recommend knowing a few laws and what they do. Food, Drug and Cosmetic Act (1938) – Give authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. Covers orphan drugs.  The introduction of this act was influenced by the death of more […]

Random things they ask: Names of tests for disease states (ie: Montreal Cognitive Assessment, for example) All names are generic Know drugs with REMS programs, NTIs and Black box warnings well.