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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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Can you drink alcohol while taking clonidine?

The Checkup by Singlecare

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. Alcohols negative effects on the liver are well-documented. Does clonidine help with alcohol withdrawal?

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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. Doctoral thesis. Stockholm: Karolinska Institutet; 2023:75 pp. 9 Morris S, Salm V, Salm A.

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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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How to deal with a drug recall in pharmacy

SingleCare

Flaws in the manufacturing process can cause some drugs to be contaminated, ineffective, or labeled incorrectly. To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs.

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ICH Q6B for Analytics

PharmTech

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. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

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