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8441. Amyotrophic lateral sclerosis: developing drugs for treatment

8442. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

8443. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

8444. Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus

8445. Investigational enzyme replacement therapy products: nonclinical assessment

8446. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

8447. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products

8448. Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff

8449. Smallpox (variola virus) infection: developing drugs for treatment or prevention

8450. Compliance policy for limited modifications to certain marketed tobacco products