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Sage Therapeutics and Biogen announced Monday that the FDA has given priority review to the companies’ new drug application (NDA) for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Read More
The FDA has warned consumers not to use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination that has caused permanent vision loss from eye infections and one death. Read More
As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency. Read More
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more than just looking at metrics, according to several experts speaking at a recent FDAnews webinar. Read More
The FDA has asked for feedback on an International Council for Harmonization (ICH) draft guideline on bioequivalence (BE) studies for immediate-release solid oral drugs. Read More
In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators. Read More
Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Institute for Clinical and Economic Review (ICER) based on the available trial data. Read More
Until a withdrawal of approval of an ANDA is effective, the ANDA holder must comply with post-approval reporting requirements and payment of any required fees, the agency said. Read More