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. to include devices.

FDA 40

FDA Science Regulations Production 40

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. to include devices.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40