I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]
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 […]
The FDA continues to make drug compounding a high priority and will enforce the requirements of the DQSA. The FDA was very busy last week and, on May 13, 2020, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, issued two letters, one responding to a citizen’s petition (here) and one announcing the availability […]
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 […]
We all know that the most expensive prescription is the one the patient does not take. Certainly, there are several factors that impact the decision for a patient to fill a prescription. Failure to comply with medication directions can also impact the health of the patient. These failures to comply can lead to more expensive […]
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 […]
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 […]
Propofol is an excellent anesthetic, relatively safe with a fast induction time and relatively quick recovery time. It is used in all types of surgical and non-surgical procedures (including intubation and time on a vent if the patient is in distress). With all the COVID 19 cases and the resultant hospitalizations and ICU stays, the […]
The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic. The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]
