Defined by the US Food and Drug Administration (FDA) as a strategic development process tool, the Target Product Profile (TPP) “embodies the notion of beginning with the goal in mind.”[1] Broadly, the TPP is a template that summarizes key drug...
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Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. The product...
Bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity. Discovering and developing safe and effective new medicines is a...
The three pathways to gain approval to market a drug in the United States share many common characteristics, but each is distinctly different from the others. It’s important to know in advance the strengths and weaknesses of each approach when...
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for...
There are numerous reasons why a sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug...
Submission of an Investigational New Drug Application (IND) is a milestone in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND submission requires careful planning and strict compliance with regulatory requirements, which...
Knowing which products have verified profit potential before development begins helps defend their value to investors and reduces the risk of costly marketing errors. Working with a partner with extensive 505(b)(2) experience can offer the right process to identify products...