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FDA 2014 Approvals Outpace Those of 2013
The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.
The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.
“Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency's FDA Voice blog.
The approval pattern for the year—with a few weeks to go—shakes out as follows:
- 15 of this year's approved new molecular entities were for orphan drugs, the highest number since the Orphan Drug Act passed in 1983.
- The FDA approved almost 75% of novel drugs after one review cycle
- 57% of the approved drugs had Priority Review tags, speeding up the approval process
- 37% of novel drugs were on the Fast Track review route
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Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
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Patient Navigation in Oncology at Heart of Priority Health White House Visit
April 24th 2024On March 27, Priority Health's president and CEO, Praveen Thadani participated in a discussion on how to expand and optimize patient navigation services in oncology care, as part of the Cancer Moonshot initiative.
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Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
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The Federal Trade Commission's (FTC's) vote to ban most employers from issuing and enforcing noncompete clauses could have varying impacts on the health care workforce; federal regulators vastly under-enforced antitrust laws in the hospital sector during the last 2 decades, resulting in increased health costs; the FDA recently found genetic evidence of the H5N1 bird flu virus in pasteurized commercially purchased milk.
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