The freedom to walk, to talk, to run and play. To laugh, to hug, to eat — even breathe. Each day these freedoms are taken away from kids and adults living with muscular dystrophy, ALS and other related diseases that weaken muscle strength and limit mobility.
The Food and Drug Administration (FDA) must do everything it can to ensure clinical trials do not fail because of the COVID-19 pandemic. That's why the Muscular Dystrophy Association (MDA) is asking the FDA to take further action:
• Issue further guidance on maintaining the integrity of clinical trials to ensure that robust, conclusive data can still be submitted to the FDA upon trial completion. Without this guidance, sponsors may be continuing trials in ways that jeopardize data, or are perhaps pausing trials entirely, because the FDA has not put forward needed direction on how data gathered during this time will be interpreted.
• Ensure the guidance will be applied consistently across FDA review divisions and medical centers.
• Update the community on how neuromuscular disease regulatory review could be impacted by the FDA's all-hands-on-deck response to COVID-19.
With only 12 approved therapies for eight neuromuscular conditions, far too many patients are waiting for their very first safe and effective treatment.
Sign the petition and join MDA to urge the FDA to take additional actions to ensure clinical trails do not fail during the pandemic.
