While the Lachman Blog usually focuses on issues in drugs, devices, and biologics (the areas we consult in), we are swimmingly happy to take a walk (or dive) on the wild side to address a fishy problem that caught our attention. The FDA noted in a Federal Register Notice today (here) that contained this particular […]
FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020. The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]
In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT). A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]
One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology. Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]
The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog. The most recent post on this topic was on June 17, 2020 (here). That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters. […]
Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market. In the release, the FDA announces that it issued Warning Letters to four […]
In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”. The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]
The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here). This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record […]
I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]
Nothing is normal these days. We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives. Rules have changed to accommodate circumstances, and expectations have been colored by those changes. Take for example FDA’s Emergency Use Authorization […]
