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 FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA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

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. Still, however, it appears FDA has had enough of these 16%.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

He advises clients through all stages of the product lifecycle, including product development, trademark clearance, labelling, advertising and promotion, product launch, distribution, licensing and compliance. Lara Sophie Hucklenbroich supports counselling life sciences clients from the pharmaceutical, medical devices, and food industries.

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Paediatric Drug Dosing

RX Note

Comparison of oral versus normal and high-dose rectal acetaminophen in the treatment of febrile children, 2002 Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial, 2005 Key Messages Paediatric doses are generally based on body-weight (in kg) specific age ranges.

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Summary for Masterclass: Applicable Laws Regarding Promotional Materials in Pharma Marketing

PharmaState Academy

. ———————— Healthcare Professional Facing Advertising NDA discussed the legal regulations – UCPMP and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code) and ethical considerations surrounding the promotion of products in the healthcare industry.

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The Ultimate Guide To Using Enzymes with Hashimoto’s

The Thyroid Pharmacist

A poster presentation from April 21-24, 2002 presented in Cannes, France, found that Wobenzym , a proprietary blend of systemic enzymes, taken at a dose of five capsules, three times per day, showed very promising results in Hashimoto’s. ( * Wobenzym N is the formulation that was studied.

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Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

This big news was newly emerging research in 2002 when I started pharmacy school, 20 years after their initial discovery. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. pylori , and recommended the use of antibiotics for the treatment of ulcers.