Summary
The FDA's Center for Drug Evaluation and Research (CDER) issued a sources-sought market research notice to identify providers of a Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus. The notice specifies technical requirements (e.g., 37°C sample temperature control, adjustable stirring, simultaneous multi-sample operation with time-point withdrawal, filtering/centrifuge capability, and desired automated dilution, pH monitoring, and direct HPLC connection), plus delivery, installation, training, and a one-year parts-and-labor warranty. Capability statements (including Made in America status, SAM Unique Entity ID, and small-business representations) are due by July 16, 2026 and should be emailed to Howard.Nesmith@fda.hhs.gov.