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Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and detailed warning letter that cautioned the company against sharing equipment between the two operations. Read More
The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness, safety and public health priority from consideration of the price of medicines and their cost-effectiveness. Read More
The Centers for Medicare and Medicaid Services (CMS) should require clinical trial participation of patients seeking coverage for many new drugs, particularly those that have accelerated approval. Read More
The Health Resources & Services Administration (HRSA) has warned Merck that it could get slapped with fines for refusing to grant 340B discounts to hospitals and clinics that participate in the program. Read More
The FDA spelled out its latest thinking on demonstrating bioequivalence for topical generic drugs in four separate draft guidances released on Friday. Read More
The FDA has granted Regeneron an additional six months of pediatric exclusivity for its intraocular injection Eylea (aflibercept) as a treatment for preterm infants with retinopathy of prematurity (ROP). Read More