ICYMI: FDA and Manufacturers Map Out PDUFA Reform Priorities

According to an article via BioPharmInternational.com, “A year-long process reauthorizing the Prescription Drug User Fee Act (PDUFA) was launched July 15, 2015 with a public meeting, setting the stage for monthly discussions with industry beginning this fall and...

FDA Reportedly Remains World’s Fastest in New Drug Approvals

  According to FDANews.com, “Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap.”  For more information, visit: ...