Crawford four-month appraisal
This article was originally published in The Tan Sheet
Executive SummaryActing FDA Commissioner Lester Crawford, PhD, "is doing an awesome job," HHS Secretary Tommy Thompson tells AdvaMed board members June 20 in Washington, D.C. "He is out there to make changes. He is already making more changes in the short couple [of] months he's been here...realigning, reorganizing, putting in the risk assessment system....Whether or not he's going to get to be the commissioner I can't tell you. That's a decision for the President. But I can assure you, until the final commissioner is appointed by the President, this man is in charge, this man is going to continue to make changes"...
You may also be interested in...
ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.