Drugs

Guide on Drug Covered Product Authorizations

FDA has made available a draft guidance entitled “How to Obtain a Covered Product Authorization.” The document describes how eligible product developers can obtain such authorizations from FDA under the CREATES Act. The law provides a pathway to obtain product samples needed to fulfill testing and other regulatory requirements from brand drug makers whose products have Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use. The guidance replaces the 12/2014 draft guidance “How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD.”

CREATES also establishes a private right of action that allows eligible product developers to sue brand companies that refuse to sell them product samples needed to support their applications. “If the product developer prevails, the court will order the sale of samples, will award attorneys’ fees and litigation costs to the product developer, and may impose a monetary penalty on the brand company,” the guidance says. Under the CREATES pathway, obtaining the Covered Product Authorization from FDA is one several steps firms must take before the brand company will be required to sell them product samples, it notes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome