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Where can I find the FDA summary basis of approval?
SBAs are available through the FDAs Freedom of Information Office, 301-443-6310, and from the National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161.
Are FDA approval letters public?
The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Read more about Drugs@FDA. Database provides ability to search for inactive ingredients in approved drug products.
Where can I find FDA reports?
Recent reports on the FDAs planning, performance, budgeting, user fee programs, and other agency-wide programs. Reports and related documents issued more than 2 years ago may be found in the FDA.gov Archive .
Where can I check my FDA approval status?
To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. The FDA Orange Book contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
How do I get FDA approval alerts?
Our free e-mail alert service allows you to receive important FDA news and information as they become available. To sign up, please select the topics that interest you. To subscribe, all you need is a valid e-mail address.
Related Searches
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The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.
How do I know if a drug is FDA approved?
Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.
Related links
202276Orig1s000 | FDA
Apr 27, 2012 Food and Drug Administration. Center for Drug Evaluation and Research. Office of Prescription Drug Promotion. 5901-B Ammendale Road. Beltsville
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