FDA Releases Steps to Modernize Drug Approval Process (1)

The FDA is streamlining its drug approval process through potential structural changes and renewed emphasis on product-specific guidance.

Drug sponsors and the clinicians who review their products typically have to perform administrative gymnastics to get a new drug approved. Much of the Food and Drug Administration’s plan revealed June 4 is to remove those administrative barriers by increasing the number of offices that make decisions about drug marketing and regulatory oversight.

The agency will also engage sponsors earlier in the drug approval process and provide more product-specific guidance, said Scott Gottlieb, head of the FDA.

“This includes the more widespread ...