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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments. 314.150(c).

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guillen E, Ekman N, Barry S, et al.

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Patient Care Process

RX Note

In 2014, the Joint Commission for Pharmacy Practitioners (JCPP) - representing 11 national pharmacy organizations - endorsed a framework for providing clinically oriented patient care services called the Pharmacist's Patient Care Process. Above the evidence-based professional recommendations on disease (i.e.,

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Patient Care Process

RX Note

In 2014, the Joint Commission for Pharmacy Practitioners (JCPP) - representing 11 national pharmacy organizations - endorsed a framework for providing clinically oriented patient care services called the Pharmacist's Patient Care Process. Above the evidence-based professional recommendations on disease (i.e.,

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9% To learn more about the solutions provided by Paradigm Health, download the document below. per year and multinational studies rising by 4.9% per year over this decade.

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What You Need to Know as a Breastfeeding Hashi’s Mama

The Thyroid Pharmacist

doi:10.1155/2014/531969 [27] Alexander EK, Pearce EN, Brent GA, et al. doi:10.1182/blood-2014-12-614446 [36] Wang JW, Liao XX, Li T. doi: 10.1155/2014/602894. Epub 2014 Aug 31. Published 2014 Oct 30. doi:10.1136/bmjopen-2014-006571; Forster DA, Moorhead AM, Jacobs SE, et al. 2020;34(4):101438. J Thyroid Res.

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80 health IT & revenue cycle up-and-comers | 2025

Beckers Hospital Review

Mr. Chan has led Iodine Software to the forefront of healthcare AI by developing predictive and intelligent tools that dramatically enhance clinical documentation and revenue cycle outcomes. She has assembled a high-performing team and developed educational initiatives that improve documentation quality and provider engagement.