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March 16, 2012

Vol. 4 No. 11

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EMA Eases Drug Safety Data Submission Requirements

Heeding drug industry feedback, the European Medicines Agency (EMA) is reducing the amount of information collected from companies under provisions of the 2010 pharmacovigilance law. Read More

Devicemaker Gets Warning for Lack of Quality Policies, Training

FDA investigators found fault with Canada-based Intelligent Hospital Systems’ (HIS) failure to establish a plan defining quality practices, resources and activities relevant to its devices and its failure to spell out how quality requirements will be met, according to a recent warning letter. Read More

FDA Needs to Shift Import Safety Burden to Industry, Autor Says

As global pharmaceutical trade grows, the FDA’s model of surveillance needs revamping, including placing the burden on the drug industry to prove a product is safe before it enters the U.S., an FDA official says. Read More

Telemetry Maker ScottCare Warned on GMP Violations

The FDA has handed telemetry maker ScottCare a warning letter for a host of GMP violations at its Cleveland, Ohio, plant, including improper implementation of corrective and preventive action (CAPA) procedures. Read More

Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials. Read More

Warner Chilcott Gets Warning Citing Stability Spec Failures

The FDA wants Warner Chilcott’s Fajardo, Puerto Rico, plant to do a retrospective review of its stability program for all approved products on concerns that some may not meet specifications throughout their shelf life, according to a recent warning letter. Read More

Missing, Flawed MDR Procedures Land Warning for UK Company

A British cardiac device company earned an FDA warning letter over its failure to establish medical device reporting (MDR) procedures. Read More

Floating Insects in Filling Room Prompt APP Warning Letter

APP Pharmaceuticals received a warning letter for persistent media fill failures and recurring critters in manufacturing areas of the company’s Grand Island, N.Y., plant. Read More