Six Steps to Improve FDA Enforcement
FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.
FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.
Hamburg said that the current pathways for enforcement can be too long and arduous when the public’s health at risk. To improve the pathway, Hamburg outlined six key steps. Five of the six steps involve procedural activities and one involves the resolution of warning letters.
In one key new measure, the FDA will set post-inspection deadlines, giving firms a deadline of 15 working days to respond to inspection findings. “This will help FDA issue warning letters in a timely basis and facilitate prompt corrective action,” she said. The FDA will also prioritize enforcement follow-up, either through an inspection or an investigation, to assess whether the necessary changes have been made.
Also, the agency will no longer issue multiple warning letters before taking enforcement action. And in some cases, she said, the FDA may take immediate action to protect public health without the issuance of a formal warning letter. One additional step involves the development of a formal warning letter closeout process. Once a firm has fully corrected the violation raised in a warning letter, the agency will issue a “close-out” letter. The agency will also indicate on the web site that a close out has been issued.
Hamburg said that and effective enforcement strategy ultimately creates public confidence in FDA oversight, which in turn keeps trust in the safety of FDA-regulated products from eroding. “Such confidence is critical in the long-term interest of both consumers and industry,” she said.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
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.
Beyond SaaS: How Service-as-a-Software and Agentic AI Are Powering Labs of the Future
July 18th 2025Globally, scientific labs generate unprecedented volumes of data through cloud-based platforms, yet most of this valuable information remains fragmented and buried across different systems. While traditional software-as-a-service (SaaS) solutions have addressed the accessibility problem, labs still struggle with data overload, forcing scientists to spend countless hours searching for information that should be readily available. This whitepaper presents AI-powered SaaS, the next advancement in lab informatics that is transforming how lab workers interact with their data, enabling natural language conversations that deliver contextualized insights exactly when needed.
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.
