The FDA has been working with the Pharmacy Compounding Advisory Committee (PCAC) since the year 2000 to develop a list of drug products that present demonstrable difficulties for compounding. Concerns relative to bioavailability, variations in batch-to-batch consistency, and dosage-form release characteristics that could present significant safety (or other) issues are outlined in and provide a […]
One of the most commonly used methods of extracting guidance on various issues from the Office of Generic Drugs is the Controlled Correspondence (CC) process. While this process is often maligned because of the high bounce back rate due to minor formatting or technical issues, the process is one of the only ways to obtain […]
Today, the FDA published a guidance titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products” (here) that provides advice on the types of changes to OTC NDA and ANDA product labeling that may be submitted in an annual report. The guidance provides for “minor changes” that may be made but also […]
A month and half after the close of the January books, we now get a look at the output and incoming workload of the Office of Generic Drugs for January 2024, the fourth month of Fiscal Year (FY) 2024. I will provide some of the highlights of the Generic Drugs Program Monthly Report, but you […]
Benzoyl Peroxide is the active ingredient in many acne creams, ointments, gels, and combination semi-solid products for the treatment of acne. These products are sold either by prescription or over the counter. Valisure is the same testing lab that uncovered the nitrosamine impurities in Ranitidine products that developed over the expiration dating life of drug […]
Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here). The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]
The Agency warns patients not to rely on glucose levels measured by the above devices unless they are reporting glucose-level data generated from an FDA-authorized device for measurement of blood glucose by a device that pierces the skin. The Agency says that readings from devices that do not puncture the skin may provide unreliable glucose […]
First, please be aware that many of the numbers you may have seen reported in our blog posts for various OGD actions were reported for Fiscal Year 2023, which ran from October 1, 2022 through September 30, 2023. The Office of Generic Drugs 2023 Annual Report (here) is a bit different as it reports OGD actions from […]
Based on approvals posted through February 16, 2024, the OGD has issued 28 full-approval actions and 5 tentative-approval actions so far in the month of February. Given that February is a short month to start with and has one federal holiday, we may get additional help as it’s a leap year and the additional day may […]
Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration fee. When this draft is finalized, it will supplement the Medical Device User Fee Small Business Qualification and Certification Guidance and address the waiver provisions of the […]
