Woodcock, Califf Give Thumbs Up To Certain 21st Century Cures Provisions
US regulators offer their support for law's hiring provisions, limited population pathway for antimicrobials, and patient-focused drug development aspects; but remain mum on the funding levels.
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All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews
US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.
The latest drug development news and highlights from our US FDA Performance Tracker.