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FDA Making Drug 'Non-Approval' Letters Easier to Swallow

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The U.S. Food and Drug Administration says it wants to make it easier for drug companies and their investors when the agency decides a new drug isn't quite ready for approval.

In changes to take effect Aug. 11, the existing "not-approvable" letter will be replaced by a "complete response letter" when a drug isn't ready for sale in the United States, the agency said on its Web site.

"In the past, some drug manufacturers expressed concern that a not-approvable letter sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital," according to a 122-page overview of the new policy cited by the Bloomberg news service.

The redesigned letter, the agency said, will elaborate on what's missing from the original application, and how the company may be able to correct it.

Currently, when drug makers apply for a brand-name drug's approval, they pay application fees in exchange for a promise from the FDA that it will act within 180 days. The new rules include provisions for how long the process will be extended when the companies are asked for additional information, Bloomberg said.

The new response letter may not be as accessible to investors as the current FDA protocol dictates, prompting some critics to wonder whether shareholders will be in the dark about the status of drugs' "approvability," the news service said.

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