Concerns about product safety and stiffer FDA regulation of manufacturers may be drying up the biotech pipeline
Several recent events have focused attention on the safety and availability of new medical therapies. The debate involves FDA review procedures that-- depending on one's viewpoint - either rush unsafe products to market or harm patients by slowing the development and approval of new drugs, biologics, and other medical products. Agency officials stress the importance of a risk-based approach to regulating clinical research, manufacturing processes, and application approval procedures. They maintain that no drug or biologic is completely risk-free and emphasize the need …
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