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

FDA Law Blog: Biosimilars

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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PEM POCUS Series: Pediatric Renal and Bladder Ultrasound

ALiEM - Pharm Pearls

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Acad Emerg Med , 2018 [11] Systematic review & Meta-analysis, Multicenter, 2005 Through April 2016 N=1,773, Adults POCUS has modest diagnostic accuracy in adults for nephrolithiasis.

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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 FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

FDA Law Blog: Biosimilars

This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.”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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Episode 746: Can milrinone be used in patients on CRRT?

Pharmacy Joe

Milrinone labeling suggests a renal dose adjustment for patients with creatinine clearance between 10 and 50 mL/min but has no recommendations or data available for patients with ESRD or who are receiving CRRT.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

Following his graduate studies, Dr Hoppin was an Alexander von Humboldt Fellow at the Research Center Jülich, Center for Electronics in Germany from 2003 to 2005. Barrett at the Center for Gamma Ray Imaging. In 1998, John co-founded and was President and Chief Scientific Officer at Molecular Insight Pharmaceuticals (MIP) in Cambridge, US.

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Levothyroxine

RX Note

To ensure safe maintenance of thyroid hormone levels, authorities are adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labelled dose over the whole shelf-life. Over-replacement and under-replacement of thyroid hormone can increase cardiovascular risk.

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