Pluristem Therapeutics Inc (PSTI)

[jp7204]

FDA officials counter that creating a new pathway to approve drugs is both risky and — in the specific case cited by Thornberry — not needed. “FDA has been working closely with DoD to bring freeze-dried plasma to our troops and anticipates that these products will be fully approved for safe and effective use for our armed forces as early as 2018," an FDA official told POLITICO.

Section 732 of the Senate’s version of the National Defense Authorization Act creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm's way. The bill is in conference committee with final language expected as early as this week.