The U.S. Food and Drug Administration (FDA) is the government agency that regulates marketed drug products and approves marketing of new drug products. The FDA defines a drug product as a finished dosage form (e.g., tablet, capsule, or solution) that contains the drug (called the
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The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration’s (FDA) guidelines
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Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules
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The U.S. Food and Drug Administration approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in
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The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as
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Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical
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Year 2002, the U.S. Food and Drug Administration (FDA) published a concept paper on current good manufacturing practice for 21st
MoreA radiopharmaceutical is a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. For a product to be
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What is blood pressure? Blood pressure is the force that moves blood through your arteries. Arteries are the blood vessels
MoreThe U.S. Food and Drug Administration (FDA) is the government agency that regulates marketed drug products and approves marketing of
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