Last week, my colleague and I traveled to Bangalore to attend the PDA India Chapter’s meeting on Supply Chain Resilience & Quality Management Maturity. While I was intellectually aware of the important role that India plays in the global supply chain for pharmaceuticals, during my 2½ days at this chapter meeting, I was able to […]
According to a post yesterday (here), the Association for Accessible Medicines (AAM) Board of Directors has announced the appointment of John A. Murphy, III as the association’s President and Chief Executive Officer. Mr. Murphy will join AAM in October from the Biotechnology Innovation Organization (BIO) where he served as Chief Policy Officer. Mr. Murphy is a lawyer and, […]
It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference. This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me. I’m grateful for the friendships with my FDA colleagues that have extended beyond […]
With savings continuing to rise, are we at the apex of the climb or should we be worried? Generic drugs continue to struggle with uptake and placement on formularies, even Medicare Part B, which is where one would assume uptake would be the highest. PBMs place generics on higher tiers in favor of brand-name rebates because […]
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 […]
