In a news release on November 15th (here), the FDA announced that ”the U.S. Department of Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). This action will help ensure that COVID-19 tests are accurate and reliable.” The Trump policy was a misguided […]
In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]
Interoperability in healthcare has been discussed for decades and is one the greatest challenges to be overcome in medicine. Not only because technical barriers exist, but because physicians practice medicine and research continue to push the boundaries, creating new terms to be defined and understood. In addition, the rate of this is accelerating (witness the […]
What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA? I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]
It is not uncommon for organizations to have different IT systems for regulatory, product, and organizational information. Segregating the data, such as the QMS gate reviews, complaints, and adverse event reporting, from the product sales quota and organizational growth projections and actuals keeps regulatory auditors to the task at hand – inspecting the Quality Management […]
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 […]
FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]
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 […]
The FDA announcement (here) of its activities involved in expediting diagnostic tests for the Corona Virus (COVID 19) explains the actions that FDA has taken in response to this public health emergency. “The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the […]
Three of FDA’s Centers (CDER, CBER, and CDRH) recently published a combined draft guidance for Industry entitled Bridging for Drug-Device and Biologic-Device Combination Products (here). This draft guidance provides the FDA’s current thinking on what manufacturers should consider when they wish to bridge the data from one such combination product to another combination product during […]