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Typically, the FDA speaks to trial sponsors only within the context of a specific application, which is less of an issue when there have been recent or multiple approvals in a disease because the trial design and endpoints are clear.
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If an event requires multiple approvals, it will not be available in an approver's inbox until it's approved by the preceding approver(s).
A new fuel requires multiple approvals from many agencies.
Individual initiative was co-opted by committee; programming now required endless discussion, multiple approvals, constant oversight.
Second, regulatory approvals in multiple markets are more manageable for a bigger company.
Often, a sale or project may require multiple executive approvals on complex internal approval forms.
It has also resulted in new Current Procedural Terminology (CPT) codes and multiple insurance approvals affecting interventional pain management treatments in clinics across the country.
The delays come from the bureaucratic challenge of securing multiple ethical approvals for trials, and putting contracts between institutions in place.
The U.K.'s National Health Service has so-called trusts throughout the country that oversee medical services, and the conduct of research by NHS physicians, and the AMS report calls the need to get study approval in multiple trusts, each with its own local interpretations of clinical research regulations, the U.K.'s "single greatest barrier to health research".
This approach can enable more rapid trial closure or acceleration than trials focusing on a specific disease site, depending upon patient response rates, and could permit FDA consideration of a drug for approval in multiple disease sites [ 20].
This has resulted in the denial of H-1B status extensions even for employees who have had multiple prior approvals from USCIS.
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CEO of Professional Science Editing for Scientists @ prosciediting.com