CDER Approvals In January Came Early And Often

FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.

CDER was fast off the starting blocks in 2012, approving five novel agents in January – including a one-two punch of two with the shortest approval times in recent agency history on the last two days of the month.

The January 2012 novel approvals are dominated by oncology products (4 of 5), priority reviews (3 of 5) and small...

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