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Hurdles Ahead for Cell and Gene Therapy Makers - BioProcess ...
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Opportunities and Challenges in Biosimilar Development
WebJan 1, 2004 · In the ICH environment there is a greater possibility to exert influence at an early stage. ... 17.2 Function of Regulatory Agencies. The pharmaceutical industry is one of the utmost regulated industry globally composing of numerous different regulations; the main challenges of drug regulatory agencies are to guarantee safety, efficacy, and ... WebMar 26, 2024 · Product X was a first-in-class agent from a large pharmaceutical company in a crowded cardiology market. The initial expectations for Product X were high due to its impressive clinical trial … WebSep 23, 2024 · While the conditions may seem favorable, for those seeking funding for an emerging biotech company, there are three major challenges that may stand in the way. … phil isner attorney