The history of the issue of the ”intended use” regulations goes back to 2015, as explained in this 39-page pre-publication version of the Federal Register Notice (here), and it is quite an interesting read. The main issue surrounds the notion that, if a firm knows its product is being used for a use not in […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic. The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]
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 […]
Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs). Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]
FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here. Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]
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 […]
How do companies keep up with the rapidly changing world of drug and device regulations? Some companies have entire departments dedicated to these efforts. Other companies have people doing it part-time, perhaps as an add-on to their primary jobs. Some companies may not pay attention at all. Lachman offers a solution to this. We develop […]
