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 ?
Veeva Systems announced that Early Access Care Limited has selected Veeva Vault CDMS to provide electronic data capture (EDC), coding, and data cleaning for their upcoming expanded access study.
Atossa Genetics reported that patients and their doctors can now visit the company's website to obtain information about gaining access to the company's proprietary Endoxifen pursuant to the FDA's "Expanded Access" guidelines.
Expanded access to driver's licenses also removes the incentive for undocumented drivers to flee the scene of an accident, as it is less likely they would be detained or deported.
M2 PHARMA-September 18, 2018-AmpliPhi Biosciences Updates Positive Clinical Results for its Expanded Access Programme
The study examined all expanded access programs registered with ClinicalTrials.gov through Aug.
Senate Republican Leader Emeritus Fuller has been a champion for expanded access to broadband for her constituents.
Food and Drug Administration (FDA)-approved drugs and biologics were made available before FDA approval through expanded access programs, according to a study published online June 15 in JAMA Network Open.
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.
Voya Investment Management has expanded access to its target date mutual fund series, the Target Retirement Funds, which have been added to several leading defined contribution platforms including Paychex, ADP and Ascensus, the company said.
(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.
The FDA has placed a hold on the request for an expanded access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval.