FDA Presents Regulatory Challenges For Finished Dosage Manufacturers

The number of official actions taken by the FDA, as measured by the number of warning letters issued, increased significantly over the last 3 to 4 years. According to data from the FDA’s website, the number of warning letters issued from 2005 to 2009 averaged 487 per year. In 2010 that number jumped to 673. In 2011, it soared to 1,720, an increase of more than 150%. When the numbers for 2012 are released, it's believed the figure will again be over 1,700.

What does this mean for firms involved in pharma manufacturing? Milton Boyer, president of Oso Biopharmaceutical Manufacturing, shares his thoughts on this trend, what it means for finished dosage manufacturers, and what firms need to do to remain in compliance with FDA regulations and keep those warning letters from arriving at their door.