On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate. The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]
How do companies keep up with the rapidly changing world of drug and device regulations? Some companies have entire departments dedicated to these efforts. Other companies have people doing it part-time, perhaps as an add-on to their primary jobs. Some companies may not pay attention at all. Lachman offers a solution to this. We develop […]
Remote work by the generic drug program staff did not seem to negatively impact the approval actions for ANDAs in March. The entire generic drug program staff was likely feeling the same (or even higher) anxiety that we are all feeling, with the stay at home orders in place. Speaking from experience, the coordination for […]
March 2020 has got to go down in the history books as one of the most disruptive months of the last forty-four years (that is how long I have been in the pharmaceutical arena). COVID-19 is running rampant across the country. Many states are in lockdown and social distancing seems to be the new norm. […]
As the coronavirus spreads around the globe, unfortunately so do cyber-criminal attacks. Cyber criminals see this as a golden opportunity to capitalize. Hackers leverage the panic, confusion, and misinformation to transmit malware, breach computer networks, set up malicious websites, and launch social engineering attacks. Early on in the coronavirus pandemic, the Cybersecurity and Infrastructure Security […]
Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]
The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]
In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID […]
On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]
With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]
