Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines.
Key Points:
..Congress authorized FDA to collect increased total annual user...more
New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016.
On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more