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 […]
Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program. There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic […]
On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate. The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]
If you are not registered as an outsourcing compounder but are a pharmacy/hospital-based compounder of sterile products, FDA has provided advice for you if the garb that you need (including masks and gloves) are in short supply. The document does not detail outlining the steps that such compounders can take help assure the sterility and […]
On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages. In this Q&A, FDA provided the following guidance: Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]
FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year. In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]
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 […]
Training of employees remains a hallmark of the industry’s ability to deliver high quality medicines, devices, and diagnostics. Training is a crucial activity, now, more than ever, in this rapidly changing environment. During this period of social distancing, when the experts cannot travel to your site to perform training, that does not mean that this […]
The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here). The CDRH says the relaxed policy will remain in effect […]
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 […]
