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FDA Amendments Act’s One-Year Anniversary: For Better Or Worse

Executive Summary

At the one-year anniversary of the FDA Amendments Act, the agency's record is mixed in meeting its increased responsibilities and authorities the law requires

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The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months

FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on roughly one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March.

The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months

FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March

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