FDA Details CPA Process For Generic Makers Seeking Brand Drug Samples

FDA on Wednesday (Sept. 21) published a draft guidance that explains how drug makers can obtain a so-called covered product authorization to access product samples of reference drugs that are subject to a risk mitigation strategy. The CPA pathway was created under the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act that was enacted in December 2019. CREATES allows makers of generic and 505(b)(2) drugs and biosimilars to sue brand companies that refuse to provide product samples that...