Minsk, Nguyen and Cohen Publish Monograph for FDLI

Alan G. Minsk, Lanchi Nguyen and Diana Rusk Cohen recently authored a monograph for the Food and Drug Law Institute (FDLI) titled The 505(b)(2) New Drug Application: The Essential Primer. The monograph is the final chapter in a six-part FDLI series on drug regulation. For drug manufacturers, the monograph offers insight into the 505(b)(2) new drug application process by explaining the applicable law and issues to consider when deciding whether to pursue the 505(b)(2) regulatory pathway to drug approval.