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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3

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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

So much smaller, much leaner and definitely more startup mentality. And we’re trying to get on the line with a pharmacy and they’re working on getting a license in a certain state, so understanding pharmacy law, my MPJE definitely came in handy. So there’s still definitely a lot of PharmD in there.

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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

EFPIA highlighted that the legislation would apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes. However, not all PFAS have the same hazardous properties with some considered of low concern by the Organisation for Economic Co-operation and Development (OECD), EFPIA noted.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

Here, the draft guidance states that the appropriate timing for an INTERACT meeting should be when a sponsor has identified a specific product and has conducted some preliminary proof-of-concept (POC) studies but has not yet designed and conducted definitive toxicology studies.

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Cereal, pasta, and other food companies blast the FDA for a too-strict definition of ‘healthy’

STAT

So are the packaged food companies, the pasta industry, and the pickle lobby (yes, it exists). WASHINGTON — General Mills, Kellogg’s, and the rest of the country’s cereal makers are mad at the FDA.

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