FDA Regulations and Drug Safety Quiz

History of Drug Regulation

• The 1938 Act aimed to ensure the safety of drugs before they enter the market.
• The Durham-Humphrey Amendment of 1951 introduced the distinction between prescription and over-the-counter (OTC) drugs.

Kefauver-Harris Amendments of 1962

• The Kefauver-Harris Amendments were passed in response to the thalidomide tragedy, which caused severe birth defects like phocomelia.
• The main purpose of the Kefauver-Harris Amendments was to ensure the efficacy and safety of drugs before they enter the market.

Investigational New Drug (IND) Application

• An IND application is a critical step in drug development, allowing researchers to conduct clinical trials on human subjects.
• The purpose of an IND application is to gather safety and efficacy data on a new drug.

Dosage Form and Dosage Regimen

• A dosage form refers to the physical form of a drug, such as a pill or injection.
• The purpose of a dosage form is to ensure the safe and effective delivery of a drug to the patient.
• Dosage instructions typically include information on the route of administration, frequency, and duration of treatment.
• The dosage regimen refers to the specific schedule of administration of a drug.

Food and Drug Administration (FDA)

• The FDA plays a crucial role in the drug development process, overseeing the approval of new drugs.
• A key requirement for a new drug before it can be legally introduced in interstate commerce is FDA approval.

Controlled Substances

• The Comprehensive Drug Abuse Prevention and Control Act of 1970 consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens.
• The five schedules for drugs subject to abuse refer to the potential for abuse, currently accepted medical use, and safety under medical supervision.