November OGD ANDA approval actions totaled seventy-six, down from the ninety-three seen in October. The seventy-six approval actions consist of fifty-five full-approval actions and twenty-one tentative‑approval (TA) actions. Twenty-one TA actions is relatively high and came in second over the last FY with April 2020 generating twenty-two TA actions. In the beginning of FY 2019, […]
Based on the FDA advanced posting of material regarding the advisory committee meeting tomorrow to consider an EUA for the Pfizer vaccine, it appears that there should be clear sailing. From the materials that I was able to review, there were very few serious adverse reactions, 95% efficacy rate, and low episodes of severe disease […]
The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]
I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market. Firms need to […]
At first blush, it does not seem like we have that much to be thankful for in 2020, between the pandemic, polarized political views, a contentious election, worry about loved ones, quarantine and stay at home orders, restaurants closing and opening, only outside eating, and hospitals jammed packed and people dying, jobs disappearing and Federal […]
The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products. This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]
We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three. The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals. Good way to […]
So today, FDA posted minutes of its October 29, 2020 GDUFA III negotiation meeting with industry. Nice to see that the FDA is keeping us informed of pertinent issues being discussed. Here is the entirety of the minutes absent the attendees and the date of the next meeting. Discussion Industry provided their response to FDA’s […]
Well, here we are, at the end of the conference already. Let us look at highlights of the Day 3 activities. Dr. Alex Azar, Secretary of Health and Human Services, gave the opening keynote address and, in usual fashion, he thanked the generics and biosimilar industries for making high-quality generic drugs and biosimilars available to […]
In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic. However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern. On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]
