Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts. Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies. While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront. We want to assure you that Lachman […]
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 […]
Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers. In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here […]
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 […]
In light of the current pandemic and increased cyber threats as outlined here by the Harvard Business Review, a VPN might be a worthwhile investment in the fight against crime, especially now that many are on lockdown and are working from home. I’m sure most of you have heard the term VPN or Virtual Private […]
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 […]
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 […]
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 […]
