The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
In her third report on opioid abuse in the U.S., Sen. Claire McCaskill (D-Mo.) recommends giving the DEA more authority to penalize pharmaceutical distributors for failing to meet reporting obligations, and cites widely varying reporting numbers of big distributors as a sign of waning DEA enforcement. Read More
The FDA issued an alert Friday about a possible extortion scam targeting consumers, stating that imposters are issuing forged FDA warning letters to individuals who attempt to purchase medications online or over the phone. Read More
A newly-unsealed lawsuit by the state of Tennessee alleges Purdue violated a 2007 settlement with the state and continued to use providers with histories of misconduct to provide its products. Read More
The creation of nonprofit drugmakers could help remove the perverse incentives that keep generic drug prices high, three public health experts contend in a New England Journal of Medicine commentary. Read More
Former executives at Valeant and Philidor were convicted Tuesday of participating in a kickback scheme to ensure the drugmaker relied exclusively on Philidor for mail order pharmaceutical services. Read More