In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Phraxis Inc. today announced the successful initiation of its Post-Approval Study (PAS) for the EndoForce™ Anastomotic ...
According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...
Results from the iDose TR exchange trial showed a second administration and removal of the original implant was safe and well tolerated over 12 months.
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Medical Device Network on MSN
Intuitive receives FDA clearance for non-force feedback instruments in cardiac procedures
Intuitive CEO Dave Rosa highlighted that the clearance related to “several cardiac” procedures for non-force instruments used ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
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