Lachman Consultants recently participated in a webinar with Arnold & Porter called “FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections”. If you missed it, don’t despair – there is a recording of it, which can be found here. We hope you enjoy it, and look forward to “seeing” you at […]
Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]
Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]
Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]
“What happens if I don’t respond to my FDA-483 within 15 days?” If you find yourself asking this question, you will need a roadmap. There are steps to take to ensure you don’t miss the deadline, and details that you might need help with. The plan for responding to an FDA form 483 may follow […]
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 […]
Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts. Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies. While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront. We want to assure you that Lachman […]
Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers. In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here […]
Remember the days when the biggest concern that both consumers and the pharmaceutical industry had was about potential contamination of medications by nitrosamines? Just a few weeks ago, rumors were flying around fast and furiously among patient groups on social media, firms were issuing recalls of numerous medications, and regulators were involved in issuing policies […]
On the second day of AAM’s GRx-Biosims Conference, in Bethesda, Maryland, a session was held related to drug/device combination products. The session included several presenters from the FDA and industry. While the challenges with the drug/device combinations was well covered in the session, there wasn’t a lot of focus on the opportunities. The industry, as […]
