The Department of Health and Human Services Food and Drug Administration awarded a $1,050,000 firm fixed price contract to Academisch Ziekenhuis Leiden Division 1-4 Division, doing business as Leids Universitair Medisch Centrum, to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. This award was made under the FY21 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which sought...
This is a $497,310.00 Firm Fixed Price Definitive Contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Neo-Advent Technologies LLC, a minority-owned, veteran-owned, for-profit limited liability company, for the development of "CRITICAL PROCESS PARAMETERS FOR THE PREPARATION OF AMPHOTERICIN B LIPOSOMES." The contract has no set-aside designation and the ultimate completion date is September 22, 2017. No additional details about larger contract vehicles or...
This federal contract award, with ID HHSF223201610616A, was issued by the Food and Drug Administration (FDA) to Lake Research Partners, Inc., a small disadvantaged woman-owned business. The contract, with a ceiling value of $287,814.40, is for MCM (Medical Countermeasures) studies to enhance FDA communications. The contract has a firm fixed-price structure and a completion date of February 28, 2019. The place of performance is Washington, DC. This contract award is not associated with a larger...
B&H International LLC has been awarded a firm-fixed-price purchase order contract valued at $201,352.10 by the Department of Health and Human Services' Food and Drug Administration (FDA) to supply a spray drying system and auxiliary equipment. This award fulfills the FDA's solicitation for a mini spray dryer suitable for manufacturing spray dried phospholipid porous particles for inhalation, with a requested capability to produce particles between 1-20 micrometers. The contract has a total...
The Food and Drug Administration (FDA) awarded a $248,553.46 firm fixed price contract to the Institute For Clinical Pharmacodynamics, Inc., a for-profit organization, to develop modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This contract was awarded under the FDA's Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. The BAA...
This federal contract, awarded by the Food and Drug Administration (FDA), provides $2,565,626.00 to the Massachusetts Institute of Technology (MIT) to conduct research and development on "Technologies to Enable Continuous Production of RAAV from SF9/Baculovirus Culture". The contract has no set-aside designation. The work is being performed under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which seeks proposals across eight areas of regulatory science to...
The Department of Health and Human Services' Food and Drug Administration awarded a $5,055,634 firm fixed-price contract to Lumendata Inc., a minority-owned small business, to provide master data management informatics analysis services for the FDA's Center for Drug Evaluation and Research. This 3-year contract, awarded through a Broad Agency Announcement solicitation, aims to enhance the FDA's ability to evaluate medical products and protect consumers by leveraging Lumendata's data analytics...
The U.S. Food and Drug Administration (FDA) awarded a $901,888.19 definitive contract to the National Academy of Sciences (NAS), a non-profit organization, to produce a consensus report that identifies innovative technologies to advance pharmaceutical manufacturing. The contract, which is not set aside, was awarded on July 19, 2019 with a completion date of March 31, 2022. The report will assist the FDA's Center for Drug Evaluation and Research (CDER) in fostering the adoption of innovative...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $4,122,028.80 delivery order contract to Koniag Management Solutions LLC to obtain eight scientific contract professionals to support the research program of the FDA's Center for Drug Evaluation and Research, Office of Biotechnology Products. The contract is for a base period of performance from June 24, 2022 to June 26, 2025 in Silver Spring, Maryland and utilizes a labor hours pricing structure.
This is a $1,961,580.00 firm fixed-price definitive contract awarded by the Food and Drug Administration (FDA) to Lumendata Inc., a minority-owned small disadvantaged business. The contract, titled "Informatics Master Data Domain Analysis," supports the FDA's Center for Drug Evaluation and Research's Master Data Management program. Through this 3-year contract, Lumendata will provide data analytics and informatics services to enhance the FDA's ability to evaluate medical products and...