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Brand Name Search

RX Note

Off label use information can be found here too. 2005 SPS - Prescribing by generic or brand name in primary care SPS - Example medicines to prescribe by brand name in primary care Summary During university years, we are learning medicines by their active ingredient name.

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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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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 FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA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This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.”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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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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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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