Drugs
In general, the marketing authorization issued by the FDA is called what for a new drug.
What is a NDA?
The FDA classifies medical devices into what three categories.
What are Class I, II, and III?
IVDs are what when intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
What are reagents, instruments, and systems?
FDA categorizes herbs based on form and these two things.
What are intended use and route of administration?
Regulations for the Protection of Human Subjects is found here.
What is 21 CFR Part 50?
Growth factors, cytokines, and monoclonal antibodies are reviewed by this FDA agency.
What is CDER?
What year was the Food Drug and Cosmetic Act amended to include medical devices?
What is 1976?
What are Class I, II, and III?
Herbs are categorized into food, homeopathic drugs, cosmetics, and these two other types.
What are drugs and dietary supplments?
No clinical investigation can occur until this institution reviews and approves it.
What is an IRB?
This process is used to facilitate the development and expedite the review of drugs for serious conditions or those that address unmet medical needs, potentially leading to faster approvals and access to new therapies.
What is Fast Track?
What is a PMA?
A urine dipstick is an example of which IVD class?
What is a class I IVD?
When submitting an IND for a botanical drug product, it is not essential to identify this.
What is the primary active constituent?
When needed, medical devices use these three types of clinical studies.
What are pilot, pivotal, and post-market?
A company must first submit what to the FDA prior to conducting clinical trials.
What is an IND.
Adulteration is considered this type of control.
What is a general control?
Like medical devices, the FDA uses general controls and these controls to regulate IVDs.
What are Special Controls?
This type of claim describes the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.
What is a Structure Function Claim?
Clinical trial requirements started with this set of amendments.
What are the Kefauver-Harris amendments?
The FDA takes this number of days to review an IND.
What is 60 days?
This kind of submission creates new product categories for Class II medical devices.
What is a de novo submission?
Although both are diagnostic tests, the FDA does not regulate these tests.
What are LDTs?
Traditional use is defined by this federal agency.
What is the FTC?
Clinical trial design considers these three things.
What are arms, blinding, and randomization?