PhRMA Applauds FDA’s Review Template for New Drug, Biologic Applications

September 9, 2019

PhRMA said it “strongly encourages” the FDA’s new “integrated review process,” which combines assessments by the agency’s different disciplines into a single document for new drug applications and efficacy supplements.

As part of the new process, the agency will post a public integrated review document for an approved drug or biologic. It would replace current documentation that involves separate application review documents from each discipline.

“The updated template would be a collaborative document with input from clinical, clinical pharmacology, biostatistics, toxicology reviewers, and other disciplines based upon the issues raised by the application,” the agency said.

PhRMA believes the initiative can help the agency improve its drug approval process.

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