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 […]
Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers. We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well. Most of us think […]
The FDA issued a guidance today that describes the what, when, and how (as well as other key elements) of its Competitive Generic Therapy (CGT) process. The CGT process was originated with the passage of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. The CGT provisions permit expediting review of ANDAs for products […]
In the normal course of business, firms typically have an expiration date on their product and, when the product reaches its labeled expiration date, the product is not supposed to be used beyond that date. We all know that the expiration date on a product is usually not always a bright line after which being […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
For those of us in regulated industry, we all treat guidance from FDA with as much reverence as the tablets that Moses carried down from Mt Sinai. However, for those of us who are not employed by FDA, the processes underlying the issuance of these guidances is very opaque and mysterious, and, for those involved […]
Well, here we are in 2020, almost halfway through GDUFA II, and what do we know? We know that the OGD expects approvals to slow down, but original ANDAs to begin to fill up the system again. We have already seen the slowdown in approvals and, according to the OGD, this is likely to continue […]
