As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals. What the heck does that mean? Well, let’s take an example from this month’s approval actions. On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]
“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (PMC) is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation.” In previous years, the FDA […]
The FDA exhibits a high degree of transparency in projecting its intentions and inspection plans. One has only to look at publications such as, “An update to the Resiliency Roadmap for FDA Inspections” (here) that was issued November 2021. So, one may ask, what has happened in the meantime and what is the plan for […]
If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into. The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for […]
As Lester Holt says prior to the closing segment on NBC World News, “There’s good news tonight” – at least in terms of ANDA approval times. In its first quarterly report for FY 2023 all of the approval metrics are under 30 months for the first time that I can remember. (see chart below). This […]
After initial publication, this post was updated to provide links to the three petitions that FDA denied as mentioned above. https://www.regulations.gov/document/FDA-2020-P-1582-0005 https://www.regulations.gov/document/FDA-2022-P-0600-0005 https://www.regulations.gov/document/FDA-2019-P-5394-0004 The FDA has been struggling with the issue of CBD for quite a while. The use of CBD products in the marketplace has surged with CBD being claimed to be a […]
The biosimilars market is robust and, with continued progress, the savings to patients soar. According to FDA, there are currently 40 licensed biosimilar products and 3 interchangeable biosimilars, 24 of which are currently marketed. And since October of 2021, these products have captured between 3-89% of the market share, depending on the product. With several […]
The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation. Remember that […]
ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]
With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]
