Confused About the Global Requirements for Nitrosamines? We will Help You Navigate This Unchartered Territory! Nitrosamines are a well characterized family of carcinogens that has been identified in thousands of consumer products recently, including small molecule pharmaceuticals and other finished goods. They are produced by the chemical reactions of a nitrosating agent with structural elements […]
As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals. Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population. The good news is that the FDA […]
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 […]
A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19. Contract Pharma recently published an article authored by Keith O. Webber, Lachman Consultants. He says, “Although we are faced with significant challenges, hopefully the recently published guidance documents from the FDA in conjunction with the […]
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 […]
Well, here we are. We’ve crossed the transition date (i.e., March 23, 2020) and now the New Drug Applications (NDAs) for the biologic products that were approved by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA) should now be deemed to be Biologic License Applications (BLAs). According to the FDA’s website, a total […]
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 […]
January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents! A total of six final guidelines and one draft guideline on GT products were issued. These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]
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 […]
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 […]
