Clarification of Roles and Responsibilities and Proposed Future Reviews of and Updates to the Coordinated Framework-Part 4
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA Welcome to the fourth and final blog post in our mini-series focused on the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. In the three previous posts, we provided...read more
FDA Updated their Guidance Document about “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues and Cellular and Tissue-Based Product”.
By Nitisha Pyndiah, PhD Source: CDC/ Cynthia Goldsmith (2016). This is a transmission electron microscopic (TEM) image of the Zika virus, which is a member of the family, Flaviviridae. Virus particles are 40nm in diameter, with an outer envelope, and an inner dense...read more
Part 3 - Interagency Communication and Coordination Between FDA, EPA, and USDA By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA Welcome to part three of this mini-series revolving around the recently-released 2017 Update to the Coordinated Framework for...read more
By Nitisha Pyndiah, PhD One of the most challenging parts of your drug development is making sure that your drug does not elicit a detrimental immune response in the patient also known as immunogenicity. This immunogenic response can impact the efficacy and safety of...read more
By Nitisha Pyndiah, PhD, Consultant To follow up to our previous part 1 about the analytical data required to demonstrate interchangeability, let’s look into clinical studies required. What clinical studies are required to demonstrate...read more
By Mary Waters Cinco de Mayo is widely interpreted as a celebration of Mexican culture and heritage. Today, celebrators mark the occasion with parades, parties, mariachi music, Mexican folk dancing and traditional foods such as tacos and mole poblano and consuming...read more
By Roushan Afroze and Suzanne M. Sensabaugh, MS, MBA Near the end of 2016, the United States Congress enacted the 21st Century Cures Act to expedite the development and review of biologics that address unmet medical needs. This is to be accomplished by introducing a...read more
Mary Waters, Consultant At the DIA Regulatory, Submission and Information Management (RSIDM) conference held in Bethesda, MD, February 2018, the FDA directly stated that they would not delay the implementation of the eCTD DMF mandate again. If your...read more
Part 2: Roles and Responsibilities of the Primary Agencies that Regulate the Products of Biotechnology.
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA In part 1 of this mini-series discussing the newly-released 2017 Update to the Coordinate Framework for the Regulation of Biotechnology, we discussed some of the background relevant to...read more
By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA In 2017, a joint effort between the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) produced the “2017 Update to the...read more