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The study was in Phase 3, the final stage of clinical trials before a drug maker applies for approval.
Research that applies for approval from the U.S. FDA also must have been conducted according to FDA regulations which, except for a few exceptions, are essentially the same.
Similar(53)
"In the case of FDA-approved naloxone products, the manufacturers applied for approval as a prescription drug.
In 1995, AquaBounty formally applied for approval.
But applying for approval is still burdensome.
In Connecticut, insurers apply for approval individually.
Both companies first applied for approval in 2000.
The company plans to apply for approval in June.
So far no company has applied for approval of a SARS diagnostic test.
Miravant Medical Technologies has applied for approval of a light-activated drug, somewhat similar to Visudyne.
Many other Oregonians were contemplating applying for approval, James Romney, 56, is one.
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