FDA Roundup March 2024

Happy Friday Everyone! Welcome to the First Edition of the FDA Roundup. At the end of each month, I will post 5 things from the FDA that I thought were the most interesting. The goal of the FDA Roundup will it for it to be a quick read and give you an overview of some of the FDA initiatives that are happening in D.C. It is not meant to be as comprehensive as the AI Healthcare Report. Since this is the first edition, improvements can be made. Comment on what you think, like to see, etc.

1.Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024

The FDA announces the over-the-counter (OTC)monograph drug user fee rates for FY 24. The Federal Food and Drug Cosmetic Act (FD&C Act) permits the FDA to assess and collect User Fees from OTC manufacturers.

The facility fees remain effective until September 30, 2024.

2. FEIBA Approval Letter

In conjunction with their Biologics License Application (BLA), Takeda Pharmaceuticals also received approval for labeling changes for Anti-Inhibitor Coagulant Complex for volume and higher infusion rates in both adults and children.

3.Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access

On April 10-11th subject matter experts will speak on various parts of the generic drug assessment program. For more information on registering for this event, please click here.

4.FDA Approved Drugs

Above are the latest drugs that have gone under the FDA approval process. It is crucial to note that this list does NOT include BLAs/NDAs and those applications and parts of applications approved by CBER. This resource will be a staple in the FDA Roundup. You can also see what has been approved by sorting the data!

5.Natural History Studies and Registries in the Development of Rare Disease Treatments

On May 13, the FDA and their Rare Disease Team with the Reagan-Udall Foundation, will host a public workshop that will bring together key stakeholders.

To register for the event, please click here.