Topicals and injectables were the most common types of products to receive drug GMP warning letters in FY 2013. All 43 warning letters are listed here by dosage form with the key issues described.

Device firms closed the final quarter of 2012 with $1.1 billion in financing, led by Volcano’s debt offering. Takeovers of Gambro and PSS Medical topped the device M&A list. At $196 million, Q4 diagnostic financing was the lowest quarter of the year, but IPOs returned with three public debuts. Amgen’s $415 million acquisition of deCODE was the largest diagnostic M&A.

McKesson buys PSS World Medical. St. Jude Medical draws FDA form 483. Cibiem raises $10 million for heart failure, hypertension treatment. More news briefs.

The current specialty-dominated care paradigm for sleep apnea can't scale-up to meet the demands of an enormous and serious chronic disease. New companies help move diagnosis and treatment to the physicians that see patients first.