Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). After all, companies already have FDA-approved labels.

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

FDA 40

FDA Packaging Science Drugs 40

New Drug Approvals

APRIL 27, 2025

3] It was patented in 1966 and approved for medical use in 1974. [6] 6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. billion in 2004. [23]

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

MAY 22, 2025

4] The co-packaged combination sulbactam/durlobactam was approved for medical use in the United States in May 2023. [5] 7] References ^ Totir MA, Helfand MS, Carey MP, Sheri A, Buynak JD, Bonomo RA, Carey PR (August 2007). 7] References ^ Totir MA, Helfand MS, Carey MP, Sheri A, Buynak JD, Bonomo RA, Carey PR (August 2007).

Pharmacokinetics 62

Pharmacokinetics FDA Production FDA Approval 62

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials 82

Clinical Trials Virus Vaccine DNA 82