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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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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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Can you drink on Mucinex?

The Checkup by Singlecare

In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. Read all medication labels and consult a healthcare provider for medical advice before consuming alcohol while taking medications for cough and cold symptoms. appeared first on The Checkup.

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PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

The FDA Law Blog

This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA.

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Can I take Ozempic if I’m not diabetic?

The Checkup by Singlecare

Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use. First, using a drug off-label—especially one that’s fairly new, like Ozempic—can be unsafe.

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Can you take Wellbutrin for weight loss?

The Checkup by Singlecare

Wellbutrin is approved by the Food and Drug Administration (FDA) for the management of major depressive disorder (MDD), the prevention of seasonal affective disorder (SAD), and smoking cessation, but is used off-label for several conditions including weight loss, SSRI-induced sexual dysfunction, and attention-deficit hyperactivity disorder ( ADHD ).

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

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2005 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2012/1916). cited 2024May].

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