May was a good month for the OGD in terms of approval actions and a few other statistical parameters. The OGD issued 71 final-approval actions and 13 tentative-approval actions in May 2024. While I was off in my estimation of unofficial actions by one on the approvals (72) and tentative approvals (12) (see the blog […]
When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities? Even when outsourced, the contract giver needs to have the requisite skills to provide adequate oversight. These concepts are also summarized in the FDA publication “Q10 Pharmaceutical Quality System” regarding both […]
In a recent landmark decision, the Supreme Court struck down what is known as the Chevron decision, a 1984 case that basically gave federal agencies deference in how to interpret statutes that may be somewhat ambiguous or not completely clear. This deference was not, of course, absolute (as we will see later), but, basically, under […]
June 2024 saw 49 full-approval actions and 12 tentative-approval actions for a total of 61 approval actions. If these figures hold, June will tie with March for the lowest number of total approval actions in a month. With May standing at a strong 84 unofficial approval actions, this up-and-down month-by-month scenario appears to be the […]
I retired from the FDA about one year ago this summer. I have mixed feelings about my twenty-one years with the Agency, but I mostly reflect back on the good memories and the great people I had the pleasure to learn from and work alongside. I find myself pivoting to my second curve, as popularized […]
The manufacturing landscape for cell and gene therapies is evolving rapidly, driven by the need for greater flexibility, efficiency, and proximity to patients. Two prominent models have emerged: Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M). Both approaches have unique benefits and challenges, particularly concerning quality control and regulatory compliance. This blog explores the […]
Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues. Generic medicines play […]
In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]
No, please don’t. Environmental Monitoring (EM) program is not a “one size fits all” package. Rather, it should be customized to a particular manufacturing space and the processes used after a robust risk assessment that considers potential failure modes and then followed up, periodically evaluating past EM data. If you were to do an internet […]
The FDA released a draft guidance titled Considerations in Demonstrating Interchangeability With a Reference Product: Update (here), which acknowledges the FDA’s continued evaluation of the biosimilar data collected to date and worldwide acknowledgement that if a biosimilar is approved using the analytical methods required for approval, including appropriate in vitro testing, there should be no […]
