Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]
Although the FDA’s regulatory requirements for acceptance of vendor test results in lieu of testing is clearly specified in 21 CFR 211.84 for incoming raw materials and container closures, the FDA has not put forth specific regulations for the acceptance of single-use consumables. Biologics manufacturers may use dozens or even hundreds of different single-use consumables […]
The development of antibody-drug conjugates (ADCs) typically involves using monoclonal antibodies (mAbs) “linked” to a cytotoxic drug and used as a specific targeting mechanism to deliver highly potent drugs to a surface antigen present only on tumor cells. Think of it as the biologics version of a smart bomb, with a targeting system able to […]
On May 1, 2024, the first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes: USP General Chapter <1079.1> on Storage and Transportation […]
The Biosimilar User Fee Program has announced the new FY 2025 fee schedule in the pre-publication of the Federal Register Notice (here). The base fee amount for the BsUFA program for FY 2025 is $51,058,823, which is adjusted for inflation (this year is calculated at 4.1881%); along with factoring in other required estimated expenses, this results in […]
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 […]
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 […]
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 […]
