FDA Roundup October 2024

The Dallas Cowboys are 3-3. I hope that Dak and the team figure it out before the playoffs happen. Texas fell to Georgia 30-15 last Saturday and now sits at the number 5 spot. The number 14 Aggies are playing the number 8 LSU Tigers this Saturday. We are also 11 days away from the Election. Happy Friday everyone and welcome to the Eighth 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.

1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

The FDA recently reclassified tirzepatide to be reevaluated regarding the compounding of tirzepatide drug products during the reevaluation period.

On October 11, 2024, a court order remanded the FDA for reevaluation after the agency was sued regarding the removal of the tirzepatide injection from the shortage list. The FDA stated in its case that in reevaluation and up to 2 weeks after its decision, the agency does not intend to take any action against the respective parties for violations of the FD&C Act.

However, this particular case does NOT prevent the FDA from taking other actions against other regulatory or statutory violations, such as around quality and safety.

For the full letter of the compounding of tirzepatide drug products during the reevaluation period, please click here .

2.Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability

The FDA recently released draft guidance entitled Drug Interaction Information in Human Prescription Drug and Biological Product Labeling.”

The goal of the draft guidance is to help applicants in constructing drug interactions of content and format of labeling for human prescriptions and biological products.

The draft guidance also provides context on what to include, how to present, and how to organize the information in the labeling for human prescriptions and biological products, specifically around communication of the clinical significance of drug interactions and the use of prescription drugs by healthcare practitioners.

Please submit comments by January 21, 2025.

3. Warning Letters

The linked resource is a compilation of all the warning letters the FDA has made available to the public. You can filter the information in the following manners below:

• Issuing Office (CBER/OPDP etc.)
• Letter Issue Date(from the last 7 to 90 days)
• Letters with Responses/Closures
• Posted Date (from the last 7 to 90 days)
• Year (from 2019-2024)

The "Warning Letters Section" will now be a new "permanent section" of the FDA Roundup since it is essential to be up-to-date on any FDA-related discrepancies.

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. Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments

On October 16, 2024, the FDA announced a public meeting called "Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.”

The purpose of the meeting was to discuss the establishment of a Rare Disease Innovation Hub with CDER, CBER, and other FDA offices.

Furthermore, key stakeholders were able to provide input on the Rare Disease Innovation Hub and how the Hub can communicate with those in the rare disease community.

Please submit comments by October 31, 2024.