Tag Archives: CDER

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 […]
Posted in FDA, Legal, Manufacturing, Safety, Supply Chain | Also 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 […]
Posted in Advertising, Biotech, E-Media, FDA, Legal, pricing, Regulatory, social media | Also 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 […]
Posted in FDA, healthcare, Legal, Regulatory, Safety | Also tagged , , , , , , , | Leave a comment

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
Posted in FDA, Regulatory | Also tagged , , , | Leave a comment

Frontrunners in Innovation: New Drug Approvals 2013

Frontrunners in Innovation: New Drug Approvals 2013 Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly—it can be highly illusive.  Safe to say, however, as 2013 drew to a close,  the total number of new did not match 2012’s  high of 39. And yet, […]
Posted in Regulatory | Also tagged , , , , , | Leave a comment
  • Categories

  • Meta