At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]
At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]
The week of February 1, 2021, Lachman Consultants held their inaugural Medical Device Week: A Lachman Learning Experience™. The week combined blogs and a webinar that touched on several different topics involving AI and diagnostics, data governance, SDLC infrastructure, change control, cybersecurity, as well as organizational maturity. Despite the name of the week, many of […]
In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic. However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern. On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]
Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]
The COVID-19 pandemic is sweeping the world and companies and regulators are working hard to keep up with the increased demand for drugs and devices to treat the disease. Certain products used to treat COVID-19 patients are at risk of shortage due to this increased demand. Most notably, in the EU (which is a few […]
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 […]
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 […]
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 […]
Some time ago, we highlighted the issues that we had been facing searching FDA’s Warning Letter database in the new FDA website (FDA’s Website Re-Design – Did Something Get Left Behind?). We wanted to give you an update as to where the current status of this is. Since drafting this post, we received some email […]
