If you are not registered as an outsourcing compounder but are a pharmacy/hospital-based compounder of sterile products, FDA has provided advice for you if the garb that you need (including masks and gloves) are in short supply. The document does not detail outlining the steps that such compounders can take help assure the sterility and […]
With COVID-19 still ravaging the U.S. and the world, there are many efforts to find new treatments, find old drugs that may work, and various immunological approaches that are being evaluated to fight this disease. Just out of curiosity, I took a look at the U.S. National Library of Medicine’s Clinical Trials website (here) to […]
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 […]
Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” The FDA will continue to enhance this emergency program to bring safe […]
The FDA announcement (here) of its activities involved in expediting diagnostic tests for the Corona Virus (COVID 19) explains the actions that FDA has taken in response to this public health emergency. “The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the […]
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. […]
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 […]
