Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can. For September, the unofficial approval actions look […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
It was on September 24, 1984 that Congress gave birth to the Drug Price Competition and Patent Term Restoration Act, also known today as Hatch-Waxman (at the time of the Act’s passage, it was called Waxman-Hatch because the Democrats were in power). For those of you who don’t remember or weren’t even born when Hatch-Waxman […]
Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]
Some of you have asked why we keep such a close eye on ANDA approval actions. It is a valid question. Knowing the importance of moving freight through the OGD comes from a combined 40+ years of experience, both in the OGD and in industry, and it is clear to me that this is the […]
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 […]
