Medical Devices Archives - Page 4 of 6 - Lachman Consultant Services, Inc.

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

By Webmaster Lachman Dec 08, 2020 Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

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 […]

Sep

Proposed Rule on Intended Use to Publish in FR September 22

By Bob Pollock Sep 22, 2020 Biologics Compliance FDA Generics Medical Devices NDA

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 […]

Aug

Do You Have Your Checkbook Ready? Be sure Clinicaltrials.gov Listings Are Made and Are Accurate!

By Bob Pollock Aug 14, 2020 BLA Clinical Trials FDA Generics IND Medical Devices NDA

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 […]

Aug

Are You Ready? Because the FDA IS Getting Ready!

By Bob Pollock Aug 13, 2020 BLA Compliance FDA Generics Medical Devices NDA

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? […]

Jun

Consolidation of Publication for EUAs for Medical Devices Announced in the Federal Register

By Bob Pollock Jun 01, 2020 COVID-19 FDA Medical Devices Regulatory Affairs

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 […]

May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

By Webmaster Lachman May 22, 2020 Compliance Drugs FDA Medical Devices Science & Technology

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 […]

May

List of Firms That Have Removed COVID-19 Diagnostic Tests

By Bob Pollock May 21, 2020 COVID-19 FDA Medical Devices Regulatory Affairs

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 […]

Apr

FDA Launches Webpage on COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

By Linda Evans O'Connor Apr 27, 2020 Biologics COVID-19 FDA Generics Guidance Medical Devices New Drugs

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 […]

Apr

Lachman COVID-19 Survey Provides Interesting Insights

By Linda Evans O'Connor Apr 27, 2020 Biologics Compliance FDA Medical Devices New Drugs Pharmaceutical industry Science & Technology

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 […]

Apr

Sci-Fi to Reality!

By Pete Manger Apr 21, 2020 FDA Medical Devices New Drugs Science & Technology

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 […]

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Medical Devices