Info Sheet , Translational Pharmaceutics , Formulation Development

Accelerating Development of 505(B)(2) Product

11 August 2020

Quotient has significant experience in 505(b)(2)
product development and can support you in efficiently turning your innovative ideas into successful products. Over the past several years, the FDA’s 505(b)(2) regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules. There has been an increasing number of product approvals in the US using this approach and similarly, in the EU, the Hybrid Medicine Authorization process can provide new product opportunities for previously approved compounds.

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11 August 2020