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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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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 FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA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This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.”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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Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products

Pharma in Brief

Background The prior version of the Distinction Guidance was last updated in August 2005 (the Old Guidance ) and did not adequately address the evolution of advertising activities since that time, including online advertising, search engine marketing, and social media activities. Patient information.

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What makes a good (and bad) pharmaceutical forecast model

pharmaphorum

Then, the key is to create varying versions of the model that are clearly labelled and filed. #5: David James has a long history within global product forecasting and consulting and co-launched J+D Forecasting in 2005. What to do. Using the trending and event approach previously discussed is the first step. 5: Keep it simple.

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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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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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Is Stevia Good or Bad for Hashimoto’s Disease?

The Thyroid Pharmacist

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. I encourage you to read the labels and look for 100% pure, USDA-approved stevia products where possible. doi:10.1055/s-2005-837775. She also stopped baking with stevia — and was able to sleep like a baby!