Drugs

2 Guidances to Speed Generic Drug Development

FDA has published a draft guidance, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process, to assist applicants and drug master file holders to start either revisions to an existing monograph(s) or development of a new monograph(s) during the agency’s evaluation of a drug master file or drug product application. The document describes the process that allows for revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

In a statement on the guidance, FDA acting commissioner Ned Sharpless says the action will help foster generic drug development and market entry through a process to cut out the waiting period for pending monograph decisions by allowing companies to propose revisions to a United States Pharmacopeia (USP) monograph while their application with FDA is still pending. “This effort will expedite USP small molecule monograph updates, immediately following FDA approval, potentially allowing generic medicines to come to market faster,” he says.

A second draft guidance, Using the Inactive Ingredient Database, describes the database and gives recommendations for how to use it in developing drug products. The document also describes how the database can be used in evaluating excipient safety. It discusses how the database is structured, data regarding excipients in the database, and how nomenclature, maximum potency levels, and units of measure are presented in it.

Sharpless says that the guidance “may help facilitate a less extensive toxicology evaluation by the applicant and less extensive review by the agency the next time the inactive ingredient is included in an NDA, again reducing unnecessary waiting time to bring generic drugs to market.”

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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