Returning Players: Original Applications That Are Back Before FDA After A “Complete Response” Letter
Novel products that could see approval in 2012 after addressing previous action letters.
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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.