Thankfully, it looks like the FDA has been able to address its IT issues, although approvals are now appearing more than a few days after the approval letters are issued. This peek at the numbers is provided for approval information posted as of December 20th – which includes posted approvals through December 15th. As of that date, […]
The Office of Generic Drugs approved eighty-two first-time generic products in FY 2023 for fifty-two different products. For example, the OGD approved sixteen ANDAs on the same day for Lisdexamfetamine Dimesylate Capsules (the generic for Vyvanse) on August 25, 2023. Each of these is counted as a first approval because they were all approved on the same […]
Have you reviewed your audit trail lately? What is it telling you and your team? We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating? Processes in a GxP environment should be developed and implemented […]
Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.” Let’s start with the Original ANDA approval numbers. The OGD did pretty […]
This has been a long time coming! Ever since the first approval of isotretinoin (Accutane – by Hoffmann La Roche, Inc. on May 7, 1982), and the associated safety requirements associated with that product’s labeling, the requirements for the safe use of isotretinoin products have become stricter. This type of safety information and requirements for […]
Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here). This Guidance covers the following four topics: Providing quantitative efficacy or risk information for the control group, when applicable; Presenting probability information in terms of absolute frequencies, percentages, and relative […]
This blog post focuses on the unprocessed, processed, and re-processed chromatographic data (e.g., data generated using chromatographic instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Performance Liquid Chromatography (UPLC), etc.). To some operators, the unprocessed chromatographic data might not be recognized, nor would they raise any concerns with the validity of the […]
It has been more than twelve years since the concept of Data Integrity was introduced formally to industry, and widely discussed throughout the industry, and yet, to this day, we continue to see how industry struggles with it. This blog post discusses some of the fundamental topics clarifying what data integrity is and how to […]
In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]
The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]
