FDA Official: Agency Could Soon Reach 'Tipping Point' On Breakthrough Drugs

FDA officials recently voiced concerns that the agency might not be able to maintain its "all hands on deck" approach as the number of breakthrough designations increase. John Jenkins, director of FDA's Office of New Drugs, recently said the agency's ability to keep pace with breakthrough reviews in addition to other priority reviews and emerging public health issues, like Ebola, is a concern. The agency also hopes companies that were denied the designation will publicly expose their experience to educate...