What does CDER stand for?
Center for Drug Evaluation and Research
CDER is part of the FDA and oversees the regulation of human drugs.
What is the role of the Office of Regulatory Policy (ORP) within CDER?
Provides oversight and leadership in the development of policies and procedures related to drug regulation
This includes compliance with the Federal Food, Drug, and Cosmetic Act and the Freedom of Information Act.
What are the key functions of the CDER Office of Communications?
- Provides strategic communication advice
- Develops public communication initiatives
- Ensures consistent branding and messaging
- Manages risk communication and health literacy research
The office supports FDA’s mission to protect and promote public health.
What does the CDER Office of Surveillance and Epidemiology (OSE) evaluate?
The safety profiles of drugs available to American consumers
It uses post-marketing surveillance and risk assessment programs to identify adverse events.
What is the primary goal of the CDER Office of Compliance?
Promotes and protects public health by minimizing consumer exposure to unsafe drugs
This includes developing compliance programs and monitoring drug quality.
What is the overall objective of the CDER Office of New Drugs (OND)?
To ensure that safe and effective drugs and biologics are available in the U.S.
This includes regulating investigational studies and making marketing approval decisions.
What is the purpose of the CDER Office of Pharmaceutical Quality (OPQ)?
To streamline quality functions across review, inspection, and research
It oversees drug quality throughout the lifecycle of a drug product.
What is the mission of the CDER Office of Generic Drugs (OGD)?
To make high quality, affordable medicines available to the public
It reviews generic drug applications to ensure safety and effectiveness.
What is Vioxx classified as?
A non-steroidal anti-inflammatory drug (NSAID)
NSAIDs inhibit the action of the enzyme cyclooxygenase (COX).
When was Vioxx approved by the FDA?
1999
It was initially marketed as a safer alternative to older painkillers.
What significant risk was associated with Vioxx that led to its withdrawal?
Increased risk of heart attacks and strokes
This was revealed through various epidemiological studies.
What was the outcome of the Vioxx withdrawal in 2004?
Merck withdrew Vioxx from the market
By that time, an estimated 20 million Americans had taken the drug.
What did the Generic Drug User Fee Amendments of 2012 (GDUFA) accomplish?
Provided additional funds, staff, and authorities to speed access to safe generic drugs
It expanded user fees to all firms manufacturing human generic drug products.
What was the estimated number of heart attacks caused by Vioxx according to research published in the journal Lancet?
88,000 Americans
Of these, approximately 38,000 died due to complications related to the drug.
