We Are Back in the Saddle! FDA Roundup August 2024

We are back! August Recess is coming to an end and college football is starting up! For those who are interested, my golf swing has improved too! The best time of the year is about to begin. Happy Friday everyone and welcome to the Sixth 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 be for it to be a quick read and give you an overview of some of the FDA initiatives in D.C. It is not meant to be as comprehensive as the AI Healthcare Report(which will be back live next Monday!)

1. Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study

The FDA has published a notice in the Federal Register about an upcoming Patient Engagement Advisory Committee Meeting.

The objective of the meeting is to provide the FDA with suggestions about regulatory issues.

The meeting will be held on October 30, 2024, from 10:00 a.m. to 5:00 p.m. EST and will be open to the public.

2. Biosimilar User Fee Amendments

The FDA has released FY 25 Biosimilar User Fee Rates. The chart is included in the link.

3. 9 Things to Know About CDER’s Efforts on Rare Diseases

CDER has been active in its efforts to expedite the drug approval process for rare diseases. Included in the link are 9 things that CDER is doing, which range from the organization launching the Accelerating Rare disease Cures (ARC) Program to public-private partnerships to help the FDA in drug development for rare diseases.

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. FACT SHEET: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation to Lower Costs for Millions of?Americans

The White House released a fact sheet earlier this month about the first 10 drugs selected for the Medicare drug price negotiation program.

Below are the first 10 drugs that are up for Medicare Price Negotiation:

The prices negotiated by HHS for the mentioned drugs above will decrease between 38% to 79%.

The new prices for those with Medicare Part D will go into effect in 2026.