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Drugmakers have asked for several clarifications in the draft guidance the agency released in December on the use of statistical approaches in bioequivalence (BE) studies.
A Florida district judge said Tuesday that the nearly 50,000 complaints filed against multiple drugmakers alleging Zantac (ranitidine) causes cancer cannot form larger multi-plaintiff injury cases and must proceed individually.
The European Medicines Agency’s (EMA) policy on interchangeability of biosimilars relates only to the active substance and formulated product, the agency said in a clarifying statement.
An Italian manufacturer of injectable drugs, Laboratorio Italiano Biochimico Farmaceutico Lisapharma, earned a Form 483 after an FDA inspection turned up evidence of microbiological contamination in supposedly sterile drugs.
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 proceed a lawsuit accusing the companies of indirectly funding terrorist acts in Iraq. Read More
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. Read More
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. Read More
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. Read More