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Faster Access to Drugs for Serious Diseases

This act aims to speed up the approval process for new drugs treating serious or life-threatening diseases. This means patients could gain quicker access to innovative therapies that might improve their health or save their lives. It also introduces new rules for monitoring the safety and effectiveness of these drugs after they are released to the market.
Key points
Accelerated Drug Approval: Drugs for serious conditions can be approved faster if early studies show promising results.
Increased Therapy Availability: Patients with serious illnesses may get quicker access to new, potentially life-saving medications.
Post-Approval Monitoring: Pharmaceutical companies will need to conduct additional studies after a drug is on the market to confirm its effectiveness and safety.
Expedited Withdrawal Option: If a drug proves ineffective or unsafe, its approval can be quickly revoked.
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Additional Information
Print number: 117_HR_6996
Sponsor: Rep. McMorris Rodgers, Cathy [R-WA-5]
Process start date: 2022-03-08