For nearly forty years, the Food and Drug Administration (“FDA”) has required applicants seeking approval of “generic” or “branded generic” drugs under section 505(b)(2) of the Federal Food, Drug and Cosmetics Act (“FDCA”) to...more
On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more
FDA recently issued its new final guidance concerning the appropriate pathway for review of drug-device combination products, Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff. In...more
The COVID-19 pandemic presents ongoing challenges to the pharmaceutical and biologics industries, where in-person inspection of facilities is often required for FDA approval of applications to market drug or biological...more