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Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic ActDRUGS

This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States....

Human Drug ImportsDRUGS

Human drug import information including PLAIR, safe importation action plan, and personal importation policy....

FDA Takes Actions to Help Lower U.S. Prescription Drug PricesDRUGS

Today, HHS and FDA took actions to help provide safe, effective, and more affordable drugs to American patients by completing the rulemaking to allow states to import certain prescription drugs from Canada....

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Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy MedicineDRUGS

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. ...

UPDATED TIME, AGENDA, AND MEETING MATERIALS: October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement - 10/09/2020 - 10/09/2020DRUGS

October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement...

UPDATED TIME AND MEETING MATERIALS INFORMATION: October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement - 10/08/2020 - 10/08/2020DRUGS

October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement...

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)DRUGS

FDA warns against taking higher than recommended doses of over-the-counter Benadryl, which can lead to serious problems and death. We are aware of news reports of teens misusing the drug after participating in “Benadryl Challenge” on TikTok...

Americans Are Cutting Back on Sugary Drinks

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THURSDAY, Sept. 24, 2020 (HealthDay News) -- Drinking lots of sugary beverages can wreak havoc on your health, but new research finds more Americans are turning away from those high-calorie drinks. And that includes many people who used to drink large quantities of sweeten...

FDA Adds Abuse Warning to Labels for Xanax, Valium

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THURSDAY, Sept. 24, 2020 (HealthDay News) -- Reacting to an upsurge in abuse of benzodiazepine sedatives such as Valium, Xanax and Ativan, U.S. officials on Wednesday added a "Boxed Warning" to the drugs' labels, cautioning about the danger. Benzodiazepines are tranquilize...

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