Virtual Site Visit - API Feed_2024-04-22 Redacted.pdf Please see the attached Slides from the virtual site visit, SLIDE DECK - 2024-04 drug shortage API.pdf
Information provided must be provided from a nationally recognized source, monitored, and updated regularly by following up with drug manufacturers. Drugs on shortage or backorder must include National Drug Code (NDC) with the date of shortage. As shortages are resolved, the NDC and resolution date must also be identified and updated. Information on shortages must be able to integrate into the VISN 10 Drug File Power BI Tool.
To obtain API manufacturing facility and product data that can assist CDER in programs that rely on manufacturing information for the purposes of compliance, surveillance, enforcement, drug shortages and user fee collections.See enclosed Sources Sought Notice for full detail of requirement.
For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Drug Shortage Staff (DSS) aims to minimize the impact of shortages of drug products, by working to avoid such shortages or to mitigate the effects when shortage is unavoidable.
These simulated medical Drugs will be utilized in the impatient Pharmacy Curriculum. The past five years, the Medical Education Training Campus Pharmacy Program has been researching a solution to comply with the FDA drug shortage initiative. Currently the Pharmacy Program utilizes actual "Real" medications that would be dispensed to patients in a (Live) hospital situation.
Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies, and to potential drug shortage situations, helping the Agency to make more informed decisions about matters that affect the health of Americans.See Attachments for RFP and related attachments.
Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies, and to potential drug shortage situations, helping the Agency to make more informed decisions about matters that affect the health of Americans.See Attachments for RFP and related attachments.Modification:See attachment for Contractor Questions and Government Responses.Bassed on the Contractor Questions, the
