Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and […]
In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves […]
In a pre-publication Federal Register notice issued today (here), the FDA announced a draft guidance titled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (here) to further promote the Agency’s knowledge and view that biosimilars and interchangeable biosimilars are really the same (although the Agency doesn’t come right […]
Looks like the heat of July did not put a crimp in the OGD’s approval actions, at least through mid-month! As of the posting on July 16, 2024, the OGD has issued 39 full-approval actions and 8 tentative-approval actions a total of 47, for what will be (if the approval actions continue at this rate) a very […]
As many companies around the world look to upgrade and enhance their IT systems and digital tools, many of these upgrades and implementations have limited success unfortunately. Comprehensive training programs and change management strategies alone are not sufficient. In an era when adoption of digital technologies is key to future competitiveness and company success, the […]
With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]
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 […]
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 […]
With the development of new technologies and drugs, the need for certain products to be presented as combination products for administration is becoming more and more commonplace. According to the FDA FAQs page on Combination Products (here), “Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the […]
