Biosimilars, Clinical Pharmacology, Definition and Packaging

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Biosimilars

Clinical Pharmacology

Definition

Packaging

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. What’s next? Stay tuned.

FDA

FDA Biosimilars Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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. fit in this definition.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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