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February 02, 2017
Reducing regulatory roadblocks requires more than the stroke of a pen.
February 01, 2017
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
January 25, 2017
FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.
January 11, 2017
FDA published a flurry of guidance documents in late 2016.
January 03, 2017
Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?
January 02, 2017
Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.
December 08, 2016
Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.
December 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
December 01, 2016
The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.
November 18, 2016
Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.