FDA
Find information on FDA's approved non-biologic drugs, regulatory status
What is Orange book?
Insurance coverage for US citizens or permanent residents who are >65 years old
What is Medicare?
What is Phase 1?
The FDA pathway allowing approval based on surrogate endpoints
What is accelerated approval?
The primary role responsible for scientific exchange with other healthcare professionals
What is a medical science liaison (MSL)?
What is Risk Evaluation and Mitigation Strategies (REMS)?
Federal and state run health coverage program
What is Medicaid?
Application for a new drug when submitted to the FDA
This type of application is submitted to the FDA to request approval for a generic drug
What is an abbreviated new drug application (ANDA)?
Adverse events reported during scientific exchange must be handled by this group
What is pharmacovigilance?
Manufacturers/HCPs/the public record serious side effects and problems with drugs/medical devices
Money you pay for a service before insurance starts paying
What is a deductible?
Study with no comparator
What is a single-arm trial?
The FDA letter stating that an application cannot be approved as submitted
The timeframe to report serious adverse events to the FDA
What is 15 calendar days?
What is the Center for Devices and Radiological Health (CDRH)?
Act aims to expand Medicaid program to cover all adults, support new medical care, make affordable health insurance
A type of trial that compares a new therapy to a standard of care as opposed to a placebo
The regulatory submission used for significant labeling changes
What is a labeling supplement?
This type of data refers to information collected from clinical practice outside of randomized controlled trials
What is real-world-evidence (RWE)?
Amendment required drug manufacturers to prove a drugs safety and effectiveness not just safety before marketing
What is Kefauver Harris Amendment?
Reimbursement model pays providers for each service given
What is fee-for-service?
A statistical analysis approach that includes all randomized patients regardless of adherence
What is intention-to-treat analysis
The FDA designation granting 7 years of market exclusivity
What is orphan drug designation?
The principle that restricts proactive dissemination of off-label information
What is promotional compliance?