Center for Drug Evaluation and Research CDER

Table of Content

• FDA Monkeypox (mpox) Response
• Tobacco Products
• Products
• Recalls, Market Withdrawals, & Safety Alerts
• Disposal of Unused Medicines

Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties. At any time, and for any lawful Government purpose, the Government may monitor, record, and audit your system usage and/or intercept, search and seize any communication or data transiting or stored on this system. Therefore, you have no reasonable expectation of privacy. Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose. FDA Monkeypox Response The FDA’s multipronged response to monkeypox includes efforts in the areas of diagnostics, vaccines and therapeutics.

Food and Drug Administration's Center for Drug Evaluation and Research has reached out to its international regulatory colleagues. Focusing on Prevention to Safeguard Infant Formula FDA is working with infant formula manufacturers to maximize production and taking steps to assure the public that infant formula is and will remain safe. FDA Continues to Advance Medicines for Children Increasing the availability of safe and effective medicines for children is a key priority for the U.S. The Center for Drug Evaluation and Research performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

FDA Monkeypox (mpox) Response

"CDER World," is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes all devices/storage media attached to this system. This system is provided for Government authorized use only.

To make submissions to FDA (e.g., Establishment Registration, Product Listing and Self-ID, etc.) you must first create an account. The interest in these "live" meetings has grown exponentially with FDA working in harmonization with countries around the world. Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work. To respond to this great interest, the Center has developed "CDER World." FDA is working with U.S. government partners, including CDC, and international partners to address the pandemic.

Tobacco Products

Drug Shortages FDA works closely with manufacturers to prevent or reduce the impact of drug shortages. Food and Drug Administration , CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs.