Drugmakers have asked for several clarifications in the draft guidance the agency released in December on the use of statistical approaches in bioequivalence (BE) studies. Source: Drug Industry Daily
A federal court has rejected a lawsuit from the Pharmaceutical Research and Manufacturers of America (PhRMA) filed against HHS that would seek to block states from importing prescription drugs from Canada.…
The U.S. Court of Appeals for the District of Columbia has rejected petitions from a cohort of drug and devicemakers that seek to overrule a decision last year allowing to…
The European Medicines Agency (EMA) has launched a new pilot program that gives some study leeway to drugmakers working on pediatric investigation plans (PIP) for innovative children’s medicines. Source: Drug…
In his State of the Union address on Tuesday night, President Biden continued pressing for a $35-per-month limit on insulin for diabetics of all ages. Source: Drug Industry Daily
In a case with wide-ranging implications for how broad patent protections can be, Sanofi and Regeneron are calling on the Supreme Court to deny Amgen’s attempt to overturn an appeals…
The European Medicines Agency (EMA) is requesting public comment on its new multi-stakeholder platform, Accelerating Clinical Trials (ACT) EU, for improving clinical trials within the trade bloc. Source: Drug Industry…
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)…
Drugmakers have a long way to go when it comes to fulfilling their required postmarket reporting, according to the FDA’s most recent numbers. Source: Drug Industry Daily
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…