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Scientific guideline: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultatio...

The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above.
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FDA issues guidance detailing specific requirements for Quality Agreements for ... - Lexology (registration)

FDA issues guidance detailing specific requirements for Quality Agreements for ... - Lexology (registration) | Veille Réglementaire | Scoop.it
FDA issues guidance detailing specific requirements for Quality Agreements for ...
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Newly Added Guidance Documents

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Final Guidance on Monitoring Crude Heparin for Quality (for biologics)

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Indian pharma major to supply vaccines to Egypt - Daijiworld.com

Indian pharma major to supply vaccines to Egypt Daijiworld.com As a holding company for biological products and vaccines in Egypt, Vacsera is the only producer of vaccines and sera (serum) in West Asia and Africa and one of the main blood banks in...
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Withdrawn application: Ixinity, trenonacog alfa / trenonacog alfa, Initial authorisation

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
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Quality Agreement Dictates Price in Manufacturing Relationships

Quality Agreement Dictates Price in Manufacturing Relationships | Veille Réglementaire | Scoop.it
RT @AltheaTech: Quality and #cGMP more important than price in #ContractManufacturing relationships http://t.co/TYf9UFRtSE #Pharma
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Regulatory and procedural guideline: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure, draft: consultation open

The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure.
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EMA Draft Guideline - in conusltation until 30-August-2013

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