CDER
"We need to improve our understanding of the safety and efficacy of pharmacotherapy as it applies to individual patients and patient subsets," the agency states in a report released this week.
CDRH Seeks Comments on 510(k) Device Process
The centers will hold a public meeting and take comments on its 25-point plan to enhance and streamline its medical devices submission process.
Industry Stakeholders Hope for Introduction of 'Advanced Diagnostics' Bill in Congress This Year
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"It's a beautifully constructed bill that has been carefully put together. We hope it might get introduced this year."
Zineh recently answered PGx Reporter's questions about the agency's efforts in pharmacogenomics and personalized medicine.
At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products.