FDA Guidance Looks to Boost Generic Drug Trials

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In an effort to help speed generic drugs to market—especially those addressing the opioid crisis—the U.S. Food and Drug Administration (FDA) has issued 43 new guidances, including 26 aimed at specific drugs and 17 revisions to update and streamline the generic drug trials process.

“These updated guidances will make the process for developing low cost, generic versions of…abuse-deterrent products more predictable and practical,” FDA Commissioner Scott Gottlieb, MD, said in an announcement of the agency’s action. Clinical trials have been widely viewed as a key weapon in the uphill battle to turn the tide on opioid addiction, and represent an arena in which FDA has taken aggressive action in recent months.

Ten of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition, FDA said. This batch of new guidances, released last Friday, also includes three revised product-specific guidances for abuse-deterrent formulations of opioid analgesics. The agency seeks public comments by September 21.

Future guidances will be issued in an “incremental” manner, according to the agency.

Guidances already issued can be found listed alphabetically by drug impacted. The guidances “add to the nearly 1,600 product-specific guidances we’ve published to date across therapeutic classes, ensuring our policies and standards keep pace with the evolving science of equivalence for generics, enabling greater patient access to high-quality, affordable medicines,” Gottlieb said.

Author: Michael Causey