Biosimilars Clinical Pharmacology Packaging 
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.
The Pharma Data
MAY 2, 2022
Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.
Agency IQ
JULY 8, 2024
Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.
Agency IQ
MAY 3, 2024
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
Agency IQ
OCTOBER 27, 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.
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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