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By John W.M. Claud, counsel, Hyman, Phelps & McNamara | FDA explains how it's looking to evaluate the effects changes might have on biosimilar products' identity, strength, quality, purity, and potency. |
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A conversation with Roland Fabris, Takeda in Linz | The company broke from the norm and used a layered approach — as opposed to a linear one — to develop a new filling line for prefilled syringes of IBS therapy Entyvio. |
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By Eric Marshall, Partnership for DSCSA Governance | The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging. |
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| Development And Regulation Of Veterinary Monoclonals | White Paper | By Adam Tuszyner, Mabion | Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future. |
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