Unapproved leaks can have serious consequences, however.
Unapproved Ebola drugs, however, have been given to some patients.
Unapproved treatments have no proven benefit, the agency says.
Unapproved nitroglycerin tablets are by no means the only drugs at issue.
Unapproved use is at best worrying and unfair, and at worst dangerous and immoral.
Warner-Lambert sales representatives met with patients and recommended drugs for unapproved uses, The New York Times said, citing court documents.
Several large medical device companies have been accused of marketing their products for unapproved uses while charging the federal government, according to documents unsealed in Houston federal court.
The Coulston Foundation, a nonprofit research laboratory in Alamogordo, New Mexico, had dozens of record-keeping infractions and unapproved changes in experimental protocol, according to an internal FDA document released today by animal activists.
According to "Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process," which cites FDA data, nearly 10% of studies have issues related to patient consent, including unapproved forms, failure to obtain written informed consent, invalid consent documents and failures to re-consent to a revised protocol.
(The C.I.A. has countered that the Panetta team examined only about half the documents that were given to the committee, and that the review was an unapproved draft).
Section 7. Unapproved loans prohibited.
