Remove 2022 Remove Clinical Pharmacology Remove Packaging Remove Small Molecule
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Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. The FY 2022 decline in NME volume does not appear to reflect a new normal for agency operations. What’s next?

FDA 52
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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. And it really is the entire package that has been formed. … The principles are: What is the data, what else is known?

Science 40