What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA? I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]
We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021. Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]
We are two-thirds through the reporting workdays for the month of January 2021 and OGD has reported 35 full approval actions and 4 tentative approval actions (total 39). If the pace of approvals does not pick up in the last 6 reporting days, we are set to have a total of full and tentative approval […]
Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry. High […]
On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”. This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency. As is no surprise, FDA clearly […]
The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]
On December 28, 2020, we published a blog post on the OMUFA fee structure for new OTC reviews and facilities (here). Today, in the prepublication of the Federal Register (FR) here, the FDA abruptly withdrew the FR Notice. Looks like someone along the way goofed as the notice bluntly indicates that “[T]he Department of Health […]
Back on April 11, 2019, we posted on the Consumer Antiseptic Rubs Final Rule (here), which also addressed use of certain wipes. The notice excluded 28 active ingredients from inclusion for OTC use as consumer antiseptic rubs (for example, leave on products, not to be used with water) but deferred action on three ingredients, “benzalkonium […]
Another UFA – sounds like the noise an animal cartoon character might make. It is, however, no laughing matter. “On March 27, 2020, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act, which authorizes FDA to assess and collect user […]
FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic. While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections. Because of this issue and the Agency’s goal of being transparent, they […]
