The legislation widely known as the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), signed into law as part of the year-end appropriations legislation, is a long-anticipated provision that aims to make samples of brand drugs or biologics needed for pre-approval testing more readily available to generic companies. The CREATES Act authorizes manufacturers seeking to develop generic 505(b)(2) or biosimilar products to file civil action against brand drug or biologic manufacturers to obtain samples. This webinar will summarize the provisions of the CREATES Act and discuss its potential impact on the generics, biosimilar, and brand name drug industries.
Sharon Coleman, Senior Regulatory Counsel, FDA – CDER
Karin Hessler, Assistant General Counsel, Association for Accessible Medicines
Andrew Wasson, Partner, Haug Partners LLP
Moderated by Rachel Turow, Executive Counsel, Regulatory Law, TEVA Pharmaceuticals USA, Inc. and Member, FDLI Board of Directors
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