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The FDA wants to see both efficacy and effectiveness data in future postmarket filings to better conform to International Conference on Harmonization standards. Read More
Trade organizations appear satisfied with the FDA’s proposed goals for the next iteration of PDUFA, citing a bevy of enhancements to drug development. Read More
The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns. Read More
With strong pipelines in Europe, Japan and the U.S., regenerative medicine is poised to become a $68 billion market in the next four years, according to a new report. Read More
The House Energy and Commerce Committee advanced a bill that would grant priority review vouchers to companies that develop counterterrorism therapies. Read More