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Exceeding expectations, the success of the breakthrough therapies program has the FDA and patient advocates calling on industry to exercise self-control in requesting the designation, which grants expedited development and review.

Reflecting its "current thinking," the FDA released final guidance Tuesday on efficacy endpoints for clinical trials of non-small-cell lung cancer (NSCLC) drugs. That thinking is based on comments made at a public workshop and recommendations from the Oncologic Drugs Advisory Committee in 2003. That's not a typo.
TOKYO – Japan is taking further steps to speed up reviews of innovative new drug and medical device applications through a new Sakigake designation. Sakigake roughly translates into "leading the way."
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