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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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FDA Inspections: Lesson 1 – Interviewing Employees

The FDA Law Blog

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

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The rise of multimodal language models in drug development

European Pharmaceutical Review

Managing and integrating data from heterogeneous sources — such as genomic sequences, clinical data, biological images and chemical structures — presents a complex challenge in terms of data normalisation. Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models.

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ICH Q6B for Analytics

PharmTech

A detailed and thorough characterization is required to be presented to regulatory authorities as part of any submission for regulatory approval and marketing authorization. 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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How to use Pay Per Click Advertising to Reach HCPs in Pharma

Pharma Marketing Network

However, pay per click advertising (PPC) presents a powerful and targeted solution for pharma marketers looking to engage HCPs efficiently. Avoiding misleading claims or unapproved off-label promotions. But how can pharma marketing teams maximize the impact of PPC campaigns while ensuring compliance and generating high-value leads?

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How to help patients get ready for summer

The Checkup by Singlecare

Recommend that patients carry documentation of any required vaccines and a current list of their medications, allergies, and medical conditions. Pharmacy teams should remind patients to always travel with prescription medication in their original, labeled containers, as recommended by the Transportation Security Administration (TSA) and CDC.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.