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FDA Inspections: Lesson 1 – Interviewing Employees

The FDA Law Blog

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

The National Institutes of Health reports that in 2012, $418 billion was wasted in the US due to suboptimal use of medications. During this time frame, the pharmacy documented 152 interventions. compared with $546,082.45 for the external mail-order pharmacies. Withholding shipment saved $1.9 million in cost avoidance.

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Maximizing the MTPC Framework for Current and Future Pharmacists

PQA

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation. McGraw-Hill; 2012. Cipolle RJ.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. Available from: [link] Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. One file per product. Internet] UK Government. Under the Human Tissue Act 2004.

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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

NICE’s positive decision, which is detailed in the final appraisal document , follows an appeal against NICE’s original guidance from November 2022. The document highlighted that daratumumab in combination “increases the time until systemic AL amyloidosis gets worse compared with bortezomib plus cyclophosphamide and dexamethasone.”

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation.