FDA Regulatory Basics
Three Administrative Actions available to the FDA for enforcement of regulations.
What are: 1) Debarment; 2) Warning Letters; 3) Inspectional Observations (Form 483); 4) Suspension or withdrawal of drug approvals
There are two primary sources of safety data used for safety signal detection. One of the major disadvantages of this source is that it is estimated to capture less than 10% of actual adverse events to drugs/biologics.
What is Postmarket Safety Reporting
The cost for bringing a new drug to market is probably in this range
What is 1 - 2 billion dollars
A type of marketing application for a Class II medical device that can be demonstrated to have substantial equivalence to a currently marketed Class II device
What is a 510(k) Marketing Applications
Four common violations that may result in warning or untitled letters
•Omitting or minimizing risk information
•Making unsubstantiated claims, including superiority claims
•Overstating efficacy
•Omitting material facts
•Promoting unapproved uses
•Broadening indications
The branch of government responsible for the FDA
What is the Executive Branch
A plan developed as a component of a REMS intended to inform healthcare professionals (not patients) about product risks.
What is a Communication Plan
Preclinical testing is conducted in this test population
What is in Laboratory and Animal studies
A type of marketing application for a Class III medical device that would usually include clinical trial data
What is a Premarket Approval (PMA) Marketing Application
Promotional marketing must be restricted to information contained in this document or content that is consistent with this document based on guidance
What is the package insert
The only governmental agency that can bring criminal charges
What is the Department of Justice
Homogeneity of the patient population is one of the limitations of this source of safety data
Clinical trial experience
This phase of clinical trials is usually conducted in healthy volunteers, but may be conducted in patients with the disease understudy in some situations
What is Phase 1
This type of FDA exemption permits the human clinical testing of an investigational device to collect safety and effectiveness data
What is an Investigational Device Exemption (IDE)
This is the type of ad that a company may use that discusses research being conducted in a certain therapeutic area, but does not mention a proprietary or established name of a product
What is an Institutional Ad
The FD&C Act was enacted in 1938 as a result of manufacture of this product without safety testing
What is Sulfanilamide Elixir
Postmarketing 15-day expedited alert reports are required for these types of adverse events
What are serious and unexpected events
Preclinical investigations should follow these quality regulations and requirements
What are Good Laboratory Practices
This type of FDA exemption is available for orphan devices and exempts the requirement to demonstrate device effectiveness.
What is a Humanitarian Device Exemption (HDE)
This type of promotional advertising is not allow for drugs with a 'black box warning'
What is a Reminder Ad
These Amendments were enacted as a result of the thalidomide tragedy and for the first time required both safety and efficacy testing prior to market approval
What are the Kefauver-Harris Drug Amendments
This is one of the more common reasons that an adverse event would be considered Serious
Inpatient hospitalization or prolongation of hospitalization
This type of application requires filling with the FDA within 30 days prior to starting clinical trials
What is an Investigational New Drug Application
For a combination product this describes the component that makes the greatest contribution to the overall intended therapeutic effect and establishes the FDA reviewing center
What is the Primary Mode of Action (PMOA)
Promotional materials must be submitted to the FDA at time of first use except for products approved under this mechanism
What is Accelerated Approval