As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
Looks like we all will be doing a lot of reading and assimilation of new information in 2021. The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year. While there are a number […]
The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products. This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]
While there is nothing like being together, the COVID pandemic has kept us apart and so it is for the AAM conference. Getting used to the format was easy but it ain’t the same! While there were some minor technical glitches, the conference went off without a major hitch. Dan Leonard, the new President and […]
The Association for Accessible Medicines released its 2020 Generic Drugs and Biosimilars Access and Savings in the U.S. Report (here) yesterday, outlining the savings that these products brought to American consumers in 2019. “In 2019, according to data provided by IQVIA, U.S. savings from generic drugs added up to $313 billion—including $96 billion and $48.5 […]
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 […]