Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]
Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers. At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]
The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance. The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]
It is always interesting to see how the Agency works when one action could trigger another action. In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]
Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act. According to the FDA, “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is […]
There has been turmoil in the world; everything seems to have gone crazy. It’s hard to find faith or even truth in our politicians. Laws have been broken and our democracy was almost broken. But, with the 2022 mid‑year election, we seem to have taken a step back from the precipice. In thinking about our […]
The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]
As of November 16, 2022, the OGD has published the issuance of thirty‑three full‑approval actions and four tentative‑approval actions. With Thanksgiving around the corner and the predictable number of staff off on PTO, the back‑end of November might not be as productive as the first half. We will keep an eye out and post an […]
At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes. He outlined a number of these changes from GDUFA II […]
One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs. The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]
