Category Archives: Legal

Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
Also posted in FDA, Manufacturing, Safety, Supply Chain | Tagged , , , , , , | Leave a comment

Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
Also posted in Advertising, compliance, Emerging Markets, FDA, Global, Manufacturing, Marketing, People, Regulatory, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , | Leave a comment

FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center […]
Also posted in Advertising, Biotech, E-Media, FDA, pricing, Regulatory, social media | Tagged , , , , , , , | Leave a comment

Momenta CEO Rebuffs Teva's Copaxone Defense

Momenta Pharmaceuticals’ CEO Craig Wheeler said comments made by Teva leadership about a “purported” generic of Copaxone are “kind of humorous.” Teva’s Copaxone, a multiple sclerosis drug that earns nearly $4 billion a year, is approaching patent expiry – and possible generic competition – on May 24. Assuming FDA approves a generic version of Copaxone, […]
Also posted in Biotech, FDA, IP, leadership, People, pricing, R&D, Regulatory, Strategy | Tagged , , , , , , , | Leave a comment

FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
Also posted in FDA, healthcare, Regulatory, Safety | Tagged , , , , , , , , | Leave a comment
  • Categories

  • Meta