What is the purpose of the Kefauver-Harris Amendment?
An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes.
What was the drugs name that sparked the Kefauver-Harris Amendment to the Food Drug and Cosmetic Act of 1962?
Thalidomide Tragedy
The primary reason the amendment was passed in the United States was due to the Thalidomide Tragedy that occurred in Europe. The drug thalidomide became available over-the-counter in Germany starting in 1957.
What is the Kefauver-Harris Amendment quizlet?
Drug efficacy amendment. What was the purpose of the Kefauver-Harris Amendment? All new drugs marketed in the US must be safe and effective. Regulates drug advertising.
What happened after the Kefauver-Harris Amendment of 1962 quizlet?
What happened after the Kefauver-Harris Amendment of 1962? The U.S. Supreme Court determined that generic drugs are new drugs. The efficacy requirement was applied to drugs marketed between 1906 and 1962. The FDA will approve the product as GRASE (generally recognized as safe and effective) and not a new drug.
What is the Sherley Amendment?
1912 Congress enacts the Sherley Amendment to overcome the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
What are prescription nonsteroidal anti inflammatory drugs NSAIDs primarily used to treat?
NSAIDs are used primarily to treat inflammation, mild to moderate pain, and fever….For what conditions are NSAIDs used?
- headaches,
- arthritis,
- ankylosing spondylitis,
- sports injuries, and.
- menstrual cramps.
When was the drug amendment to the FDCA enacted quizlet?
In 1996, the U.S. Congress enacted the Medicinal Device Amendment to the FDCA.
Which of the following is an FDA requirement of a generic drug quizlet?
-Generic drugs must be chemically equivalent with trade name drugs.
What is a measured amount of drug called?
A dose is a measured quantity of a medicine, nutrient, or pathogen which is delivered as a unit. The greater the quantity delivered, the larger the dose. Doses are most commonly measured for compounds in medicine.
Who was president when the Drug Efficacy Amendment was passed?
Also known as the Drug Efficacy Amendment, this amendment was signed into law by President John F. Kennedy on October 10th, 1962.
Who was the FDA reviewer who refused to approve thalidomide?
Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use. It introduced a “proof-of-efficacy” requirement for the first time. In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments.
Who was the FDA officer who refused to approve Kevadon?
Those looking on include Frances Kelsey, second from left, the FDA medical officer who refused to approve the new drug application for Kevadon, the brand name for thalidomide in the United States. Get this and other FDA history photos on Flickr .
What was the drug efficacy study in 1962?
Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA. The Drug Efficacy Study Implementation was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.