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PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals

Posted 11 April 2017 | By Zachary Brennan Michael Mezher 

PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.

The comments were made in response to FDA's assessment of its program for enhanced review transparency and communication for new molecular entity new drug applications (NME NDAs) and original biologics license applications (BLAs), which was agreed to as part of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and is slated to continue in PDUFA VI.

In November 2016, FDA released a final report on the program, which found the program had a statistically significant impact on increasing the number of products approved during their first review cycle.

And while PhRMA says the program has been successful overall, the industry group says there are several areas that can be improved going forward.

"To date, the Program has proven to be effective in increasing the likelihood of first-cycle approval for [new molecular entity new drug applications] NME NDAs and original [biologics license applications] BLAs," PhRMA says, noting that the rate of first-cycle approvals for products reviewed under the program was almost 80%.

However, PhRMA said it agrees with a finding in the final report that highlighted the expectation that extending the goal date to review a major amendment should lead to approval in the first cycle rather than requiring resubmission and a second cycle of review.

PhRMA also supports the recommendation that FDA should examine the process for disseminating inspection information and encourages the agency to improve communication of inspection information between relevant offices, review divisions and sponsors.

"PhRMA is pleased that the Agency is undertaking a review of inspection information flow, considering that the final report states that applications receiving on-time inspections received first-cycle approvals over one and a half months earlier than those applications that did not receive on-time inspections," the comment says.

PhRMA Comment


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