Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives. Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]
Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry. High […]
The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]
In any analytical laboratory that performs cGMP testing, data review is required. However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore. The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation. The role of the data reviewer is to […]
Nothing is normal these days. We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives. Rules have changed to accommodate circumstances, and expectations have been colored by those changes. Take for example FDA’s Emergency Use Authorization […]
Need answers to your urgent life science questions? Lachman Consultant Services, Inc. (Lachman Consultants) has launched Lachman OnCallTM GMP Teleconsulting. It’s your opportunity to speak to our Subject Matter Experts (SMEs) regarding your questions as they occur. Whether you have questions about compliance or a complex scientific or technical issue, we’re here and ready to […]
In a rush to get serology tests out for public testing, it appears that the FDA hopped, skipped, and jumped a bit too far by not first requiring at a minimum, review of the tests and the validation of the tests through an Emergency Use Authorization (EUA) prior to them going on the market. There […]
Lachman Consultants recently conducted a survey of professionals working in the pharmaceutical, biotechnology, medical device, and other regulated sectors related to the greater life sciences industry with the goal of taking the “pulse” of the overall organizational and industry impact of the COVID-19 pandemic. The results of the survey can be found here. A few […]
Science fiction has always been the white board for technological innovation. Think of all the books and/or movies you have digested. How many times have you said, “well, that will never happen?” And looking back, how many futuristic concepts have eventually become reality? More than you may realize. Let me give you a few fun […]
The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]
