When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]
The FDA announced the FY 2021 biosimilar user fees this morning on its Federal Register pre-publication page (here). The new fees can be found in the table below. BSUFA FY 2021 User fees Fee Category Rates for FY 2021 Rates for FY 2020 Percent Change Initial BPD $102,494 $117,987 -13.2% Annual BPD $102,494 $117,987 -13.2% […]
Last Friday (June 26, 2020), the Trump administration filed a legal brief with the U.S. Supreme Court requesting that the court find the Affordable Care Act (ACA) to be unconstitutional and, therefore, struck down in its entirety. Regardless of one’s opinion of the merits of the ACA to provide healthcare coverage for underprivileged Americans, there […]
Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the […]
Our own Keith Webber originally provided very detailed information and helpful hints in his August 2019 blog (here) regarding FDAs transition of certain NDAs to BLAs under the BPCI Act. So, although this may not be “new” news, we think it’s worth a quick trip down memory lane, as the implementation date quickly approaches. Let’s […]
February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here). In this notice, the FDA had proposed a pilot program related […]
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus […]
Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here). The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner. Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues: Gaming the system through REMS and restricted distribution […]
