FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

January 3, 2018, Zachary Brennan reports in RAPS Regulatory Focus that “Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.”

Here’s a link to the full story, the new draft guidance, and the MAPP.

Contact us for help designing your PK study, filing your biowaiver, or characterizing your complex drug product.