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 […]
Well, the holiday season may produce a “December to remember”, to quote a car manufacturer’s favorite tag line at this time of year. What we don’t know is will it be good to remember or not so much. December usually is one of the highest months for approval actions with the last three Decembers producing […]
Today, December 17, 2020, the Vaccine and Related Biological Products Advisory Committee meeting discussed the Moderna vaccine. That vaccine is an mRNA vaccine, much the same as the Pfizer-BioNtech vaccine. To remind you, the mRNA vaccine: Does not replicate Does not enter or integrate into DNA And the Moderna vaccine does not contain any preservatives […]
While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]
Oh, what a year it has been! Political turmoil topped only by the devastating novel coronavirus. With a vaccine EUA and vaccine on the way, perhaps 2021 will see an attenuation of the Covid-19 pandemic and our businesses and the world will start to open up again. Small businesses have been devastated, the world has […]
There’s still time to register for Lachman Consultants’ free webinar, “Looking Ahead: Virtual Auditing for FDA Inspection Preparedness: Right Now, Next Year and Beyond.” The event, which takes place Tuesday, December 15, 2020, from 11:00 am to 11:45 am EST, is an in-depth look at how organizations regulated by the FDA can utilize new virtual […]
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, […]
Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine. I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study. […]
