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FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

The FDA Law Blog

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Does mirtazapine cause weight gain?

The Checkup by Singlecare

Food and Drug Administration ( FDA ) to treat major depressive disorder (depression) in adults, and it is sometimes used off-label as an appetite stimulant. A 2001 clinical study found that 21% of self-reported weight gain occurred after 12 weeks of mirtazapine treatment. Why does mirtazapine cause weight gain?

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Adderall XR generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2001 , Adderall XR has become a popular medication for managing symptoms of ADHD. What are the off-label uses for Adderall XR? In addition to ADHD, Adderall XR is sometimes used off-label for various purposes or other medical conditions. Following its approval by the U.S.

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Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

PharmaShots

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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OTC antiemetic medications: Relief for nausea and vomiting

The Checkup by Singlecare

Be sure to follow the dosing instructions on the label for your child’s age. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting. Antiemetic side effects Most OTC antiemetics are well-tolerated and safe if taken according to the labeled instructions.

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Can tramadol be used for sleep?

The Checkup by Singlecare

Drug Enforcement Agency has labeled tramadol as a class IV controlled substance because it has a potential for dependence, abuse, and misuse. Food and Drug Administration (FDA) for pain treatment, not sleep disorders. Even so, it’s sometimes prescribed off-label for sleep. Besides all that, the U.S.

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