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2. Title 21 of the Code of Federal Regulations - Wikipedia

   en.wikipedia.org/wiki/Title_21_of_the_Code_of...

   Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

3. Food and Drug Administration - Wikipedia

   en.wikipedia.org/wiki/Food_and_Drug_Administration

   The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

4. Approved Drug Products with Therapeutic Equivalence ...

   en.wikipedia.org/wiki/Approved_Drug_Products...

   inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

5. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

6. Fast track (FDA) - Wikipedia

   en.wikipedia.org/wiki/Fast_track_(FDA)

   Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.

7. US FDA approves Amgen drug for small cell lung cancer - AOL

   www.aol.com/news/us-fda-approves-amgen-drug...

   The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...

8. Medication package insert - Wikipedia

   en.wikipedia.org/wiki/Medication_package_insert

   For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the ...

9. Why compounders and telehealth providers are undeterred by ...

   www.aol.com/finance/why-compounders-telehealth...

   When the FDA announced Eli Lilly's active ingredient for diabetes drug Mounjaro and weight-loss drug Zepbound, tirzepatide, would be taken off the list on Oct. 2 after nearly two years, it began a ...