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The move comes as the agency enters a new era of drug development applications, driven by health-inspired medicines, following the influx of health-focused companies following the COVID-19 pandemic and the surge of venture capital flooding the biotech industry. According to FDA data ranging from 1938 to 2022, the clinical research pipeline is now roughly 30% to 60% larger than what the agency had to go through in the 1990s. In addition to increased VC health funding, some factors driving this uptick include new gene therapies, academic spinouts, precision medicine, and immunotherapy. In essence, the ideas are endless, and the FDA needs to test them all.
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