Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction. Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S. While bringing jobs back to the […]
These days, everybody’s attention is focused is focused on COVID-19. However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared. In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!). Yesterday, the […]
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 […]
On Tuesday March 24, 2020, Prime Minister Narenda Modi of India ordered an extensive lockdown of all of its 1.3 billion residents. “There will be a total ban of coming out of your homes,’’ Mr. Modi said. “Every district, every lane, every village will be under lockdown,’’ he said. “If you can’t handle these 21 […]
Remember the days when the biggest concern that both consumers and the pharmaceutical industry had was about potential contamination of medications by nitrosamines? Just a few weeks ago, rumors were flying around fast and furiously among patient groups on social media, firms were issuing recalls of numerous medications, and regulators were involved in issuing policies […]
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 […]
Contract Pharma recently published an article addressing some valuable tips to make your trip along the regulatory pathway to report manufacturing changes easier. The author, Amy Schutte, Senior Associate, Regulatory Practice of Lachman Consultants says, “Change is inevitable, continuous, and reportable to the FDA when we are talking about approved human or animal drugs.” Specifically, […]
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 […]
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 […]
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 […]
