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

The FDA Law Blog

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. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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Obesity Medication Use Remains Low Among Children | ADA 2025

Drug Topics

Despite a high prevalence of childhood and youth-aged obesity, the use of medications for treating obesity is persistently low among children and young adults (YA), according to an abstract presented at the American Diabetes Association’s 85th Scientific Sessions, held in Chicago, Illinois, from June 20-23, 2025. Accessed June 25, 2025.

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From ward manipulations to 3D printing: shaping the future of personalised medication

Hospital Pharmacy Europe

5–8 Highlighting the need for evidence-based formulations A case report by Morris et al describes a serious adverse event involving the off-label use of prochlorperazine maleate tablets after the licensed liquid version was discontinued in the UK. Accessed July 2025]. Accessed July 2025]. Accessed July 2025].

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The rise of multimodal language models in drug development

European Pharmaceutical Review

Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing.

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ICH Q6B for Analytics

PharmTech

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained.

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Mounjaro long-term side effects: What to expect

The Checkup by Singlecare

It’s approved by the Food and Drug Administration to treat Type 2 diabetes and may be prescribed off-label for weight loss. The long-term side effects of Mounjaro haven’t been well documented but may include an increased risk of gallstones. It’s injected under the skin once per week to help control blood sugar levels.

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Does Aetna cover Mounjaro?

The Checkup by Singlecare

Because of those effects, Mounjaro is sometimes prescribed off-label for weight loss. This means the Aetna plan will only cover Mounjaro if the patient’s medical provider provides documented proof that the person meets certain requirements, such as a diabetes diagnosis or concerning blood glucose levels.