FDA Seeks to Advance Regulatory Science for Public Health
In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.
In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA’s plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.
In the address, given at the National Press Club, Hamburg said that the range of new drugs is “disturbingly low,” compared to the need for new therapeutics, and that we lack the ability to translate drug discovery and innovation into patient care. The document released by the FDA outlines a vision for the advancement of regulatory science and ways in which it can improve public health.
When asked about the relatively faster drug and device approval process in Europe, Hamburg expressed interest in working with European agencies. She also stated that because regulations for approvals may have been put into place a long time ago, they may need to be re-evaluated to take into consideration new technologies.
The document discusses how advances in regulatory science can speed progress in the FDA’s public health areas. It is split in two sections: the promise of regulatory science and a collaborative implementation framework. The first section provides background on the emerging field of regulatory science and explores seven public health areas in which advancements in the field can help deliver more innovative products. The second section lays out a strategic framework that will guide the FDA to advance regulatory science for protecting public health.
The full document can be found on the FDA’s web site.
www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
