The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances. Now that we’ve all had more time to carefully read and absorb the updates in the […]
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 […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events. For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]
At least unofficially, it appears the August 2024 approval numbers for ANDAs have popped back up. As of the posting on the Daily approval listing (here) and the All approvals listing (here), there were 67 full approval actions, the second highest of Fiscal Year (FY) 2024 thus far, and 15 tentative approval actions. We will […]
Just 25 days before the end of Fiscal Year (FY) 2024, the official July statistics were just posted here. The two biggest items of interest to industry from these monthly reports are usually the number of approval actions, as well as the number of ANDA receipts so, let’s get the important stuff out of the […]
Today, the FDA issued a new immediately effective guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that replaces the initial guidance by the same name that was issued on February 24, 2021. The new guidance can be found here. The industry has been awaiting the issuance of this revised guidance and the “FDA made […]
For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]
Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here). In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]
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 […]
