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United States - Life Sciences, Biotechnology & Nanotechnology - FDA Provides Updates To Congress On FDORA, User Fee Implementation

FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements. ....

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House Health Subcommittee grills FDA leaders over med device missteps

Despite the highest agency user fees on record, and granted new authorities to reform and accelerate medical device and biologics approvals, representatives questioned delays in getting products to patients faster. ....

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FDA Ensures Safety and Effectiveness of Laboratory Developed Tests

FDA Ensures Safety and Effectiveness of Laboratory Developed Tests
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New FDA Guidance on 'Remanufacturing' for Medical Devices

New FDA Guidance on 'Remanufacturing' for Medical Devices
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FDA Finalises Advice on Servicing and Remanufacturing Medical Devices

FDA Finalises Advice on Servicing and Remanufacturing Medical Devices
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