FDA Requests 5.7% Increase in 2009 Budget
The US FDA has requested nearly $2.4 billion for its fiscal 2009 budget, a 5.7% increase over the budget that FDA received for the current fiscal year.
The US FDA has requested nearly $2.4 billion for its fiscal 2009 budget, a 5.7% increase over the budget that FDA received for the current fiscal year. The request, which covers the period from October 1, 2008, through September 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees.
When questioned whether these amounts are sufficient, particularly given the serious concerns expressed in the November 2007 report by the FDA Science Board, Robert Miller, FDA Budget Formulation and Presentation Deputy Director, said the requested amounts allows the agency to “maintain momentum.”
“In an overall tight budget atmosphere, it’s allowing us to target the critical areas that have been identified by the Commissioner and the Secretary,” he said, citing the food protection initiatives, the importation of medical products, and blood and tissue issues in CBER. “So it’s a good step, it moves us in the right direction,” he said.
Of the $17.4 million allotted for medical product safety and development, $12.9 million will be used to pay for basic program costs. That leaves $4.4 million for new initiatives, including $1.5 million for blood and tissue safety, and $1.2 million for the field organization, particularly to improve the agency’s capability to monitor imports.
Under the proposed budget, user fees will increase $79 million, bringing the user fee total to $628 million. Of these, prescription drug user fees, under PDUFA, increase by almost $52 million, to a total of just over $511 million.
Funding to improve the agency’s IT infrastructure – an area of weakness identified in the Science Board report –would increase to $240 million, up from $200 million in 2007.
The 2009 budget proposal also says that the agency will seek legislation to create a pathway for approving follow-on biologics, and for user fees to cover the cost of this activity. The 2009 budget proposal, however, does not show any impact for follow-ons.
For a more detailed analysis of the 2008 budget, see BioPharm International’s February 2008 Regulatory Beat column.
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.
Biophysical and Aggregate Characterization for the Development of Biologics
June 10th 2025This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.
Psilera, Hesperos Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
