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A NATAL NATIONAL AIDS TREATMENT ADVOCACY PROJECT Free Forum EDUCATING COMMUNITIES ABOUT HIV AND HEPATITIS CHANGE IS HERE FDA Approvals & New Drugs for a Cure Hepatitis C Management Hepatitis C Treatment

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What is fda approvals?

FDA approvals are official authorization or permission granted by the U.S. Food and Drug Administration for the marketing of a new drug or medical device.

Who is required to file fda approvals?

Manufacturers or sponsors of drugs or medical devices are required to file FDA approvals.

How to fill out fda approvals?

FDA approvals can be filled out by submitting a New Drug Application (NDA) or a Premarket Approval (PMA) application, depending on the type of product.

What is the purpose of fda approvals?

The purpose of FDA approvals is to ensure that drugs and medical devices are safe and effective for public use.

What information must be reported on fda approvals?

FDA approvals typically require detailed information about the product, its intended use, preclinical and clinical data, manufacturing process, labeling, and potential risks.

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