Pacira believes new clinical trial of post-surgical pain medication will satisfy FDA concerns raised in complete response letter for its supplemental NDA.
Three years after receiving a "complete response letter" for its Exparel (bupivacaine liposome injectable suspension) supplemental new drug application for use as a nerve block, Pacira Pharmaceuticals Inc. will be presenting new data to a US FDA advisory committee.
The agency announced in a Federal Register notice to be published Jan. 11 that the Anesthetic and Analgesic Drug Products...
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
