expanded access


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expanded access

Any of several methods used by the FDA to make experimental treatments available to patients who have failed conventional treatments and are not participating in formal clinical trials.
References in periodicals archive ?
The agreement covers individual patient expanded access for AmpliPhi's investigational bacteriophage therapeutics, AB-SA01, targeting Staphylococcus aureus, and AB-PA01, targeting Pseudomonas aeruginosa.
The agreement covers individual patient expanded access for AmpliPhi's investigational bacteriophage therapeutics AB-SA01, targeting Staphylococcus aureus, and AB-PA01, targeting Pseudomonas aeruginosa.
But all party groups are more likely to believe the law has expanded access to coverage than to believe it has reduced costs.
SAMHSA finalized a rule in July that expanded access to MAT by allowing practitioners who had a waiver to prescribe buprenorphine for up to 100 patients for a year or more, to now obtain a waiver to treat up to 275 patients.
The expanded access treatment programs at BMS bridge the gap between clinical development and regulatory approval.
Biotechnology company CTD Holdings (Other OTC:CTDH) Friday reported that it will grant USD1m of its investigational drug, Trappsol Cyclo, to eligible Niemann-Pick Type C (NPC) patients participating in its newly-created expanded access programme.
3) Through the process of expanded access, FDA has allowed drugs that have not gone through the formal approval process available to patients under certain circumstances.
For these individuals, expanded access can provide an opportunity to receive investigational medication outside of a clinical trial.
The study addresses the reasons the state expanded access to postsecondary education and examines the means by which it provides access.
CHICAGO -- A new online resource will help seriously ill patients and their physicians request expanded access to investigational therapies when they have exhausted all other treatment options and the patients are not eligible for a clinical trial, it was announced at a joint news conference of the American Society of Clinical Oncology and the Food and Drug Administration.
For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.
The proposed regulations are intended to improve patient access to experimental drugs, and increase drug manufacturers' incentive to develop treatments for serious and life-threatening illnesses by permitting manufacturers to charge for a broader range of investigational and expanded access uses than is explicitly permitted under the current regulations.
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