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,...
View ArticleFDA 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...
View ArticleFDA 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...
View ArticleFDA 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...
View ArticleDrug 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...
View ArticleSocial Media Raise Concerns for Marketers, Trial Sponsors
While biopharmaceutical companies are using websites and third-party postings to provide information on medical products — despite a host of regulatory issues — social media use is in its infancy...
View ArticleFDA, Sponsors Seek Study Endpoints Earlier in Development
As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to...
View ArticleFDA Wants YOU!
A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff....
View ArticleBreakthrough Therapy Program Exceeds FDA’s Expectations
The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner, according to...
View ArticleBreakthrough Drug Initiative Success Creates Manufacturing Challenges
The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock,...
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