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New initiative will help health care providers navigate the process of submitting expanded access requests.
The law could create opportunities for hucksters and snake-oil salesmen to prey on those who are vulnerable.
The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions.
Brain cancer patient begins treatment with experimental vaccine.
Over the last five years, FDA has authorized more than 9,000 applications through the expanded access program.
We learn through scientific advances, but also by listening to patients.
We’ve taken many steps to improve our process through which patients can access promising investigational drugs.
Congress passes legislation to increase access to unapproved therapies for life-threatening diseases.
FDA will work in close partnership with patients to incorporate their experience into benefit-risk assessments.
Latest version of legislation to bypass FDA oversight must now to go back to the Senate.
Controversial legislation would have allowed patients to try experimental therapies without FDA oversight.
Ideally, all patients with advanced cancers would be in clinical trials. Until then, the right to try is an option we all should have.
Right to Try bills attack the one agency tasked with verifying the safety and efficacy of medications.
FDA commissioner Scott Gottlieb, MD, testifies before Congress on expanded access to experimental therapies.
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