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Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
Several EU member countries have suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India over serious concerns with good clinical practice. Read More
Sandoz’s bid to invalidate two patents protecting Amgen’s biologic rheumatoid arthritis therapy Enbrel was dealt a major blow last week, after a federal appeals court affirmed that a patent challenge prior to submission of a biosimilar application is premature. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
TWi Pharmaceuticals’ bid to market a generic version of Par Pharmaceutical’s AIDS drug Megace ES was dealt a major blow last week after a federal appeals court overturned a lower court’s ruling that had cleared the way for the product. Read More
A compounding pharmacy pled guilty last week to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More