Biosimilars Packaging Seminar 
Agency IQ
OCTOBER 27, 2023
Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?
Agency IQ
MAY 31, 2024
Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.
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Agency IQ
MAY 3, 2024
The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. On April 10, the E.U.
Agency IQ
OCTOBER 6, 2023
AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. What’s next? Stay tuned.
Agency IQ
AUGUST 2, 2024
Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.
Agency IQ
DECEMBER 1, 2023
December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.
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