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 52

FDA Biosimilars Science Production 52

Agency IQ

JUNE 16, 2023

0910-AI84 December 2023 Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. fit in this definition.

Regulations 40

Regulations FDA Science Production 40

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 40

FDA Science Regulations Production 40

Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement.

Regulations 40

Regulations FDA Science Production 40