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Center for Drug Evaluation and ResearchCDERFDA 2025

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The document is a memorandum from the Center for Drug Evaluation and Research regarding the review of New Drug Application (NDA) 202-276 for avanafil tablets. Initially, the NDA was not recommended for approval due to issues with batch records, labeling, and compliance recommendations. However, subsequent amendments resolved these issues, leading to a final recommendation for approval on April 17, 2012. The drug is intended for marketing in the U.S. under the trade name 'Stendra'.

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How many locations does the FDA have?

The FDAs headquarters is located in the White Oak area of Silver Spring, Maryland. The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Islands, and Puerto Rico.

What is the difference between CDER and CBER FDA?

Main differences: Types of regulated products: CDER primarily regulates chemical drugs, while CBER regulates biological products.

What are the branches of the FDA?

Information For Office of the Commissioner. Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health. Center for Drug Evaluation and Research (CDER) Human Foods Program. Center for Tobacco Products. Center for Veterinary Medicine. Office of Inspections and Investigations.

What is the Center for Drug Evaluation and Research CDER primarily responsible for?

The Center for Drug Evaluation and Research (CDER) 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.

What are the 9 centers of the FDA?

FDA is made up of nine centers. Everybodys familiar with the headquarters office, the Center for Biologics, CBER, Center for Devices, CDRH, Center for Drug Evaluation and Research, Center for Drugs, Center for Food Safety and Applied Nutrition, CFSAN, Center for Veterinary Medicine.

What are the 8 main areas that the FDA regulates?

FDA, an agency within the U.S. Department of Health and Human Services, protects public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nations food supply, cosmetics, dietary supplements, electronic radiation emitting products, and tobacco products.

What is the Center for Drug Evaluation and Research CDER?

As part of the US Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a consumer watchdog in Americas healthcare system.

Center for Drug Evaluation and ResearchCDERFDA 2025

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