Examples of Product Shortage in a sentence
The comment suggested that within 1 year of implementation of the final rule, FDA can assess whether overnotification has occurred and can revise the draft guidance for industry entitled "Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage" to include additional examples of products that are or are not likely to fall within the scope of products subject to the notification provision.
The creation of Field Management Directive (FMD) #15, Product Shortage Communication, in July 2012, established a mutual understanding of communication roles, responsibilities, and expectations involving both potential and current product shortage situations between ORA and the centers.
There is a marked difference in resource levels geographically with northern Africa, for example, being exposed to more than twice the level of solar energy as northern Europe; implying that for the same size panel the electrical output could be doubled in the former location.
An IVIG Product Shortage extenuating circumstance is when a prior- authorization/ pre-certification was obtained from the carrier for a specific IVIG product, without any approval of an alternate IVIG product, before the provider or health plan knew of or experienced any impact due to the product’s shortage.
A Review of FDA’s Approach to Medical Product Shortage, October 31, 2011, available athttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm, accessed December 2011.
These are circumstances where the provider organization, due a recent Product Shortage, could not obtain the Physician Administered Drug or the Dosage Vial of the Physician Administered Drug that was pre-authorized for the patientNote: This extenuating circumstance is a “one-time” situation when a product shortage is discovered by the provider and continuity in patient treatment does not allow sufficient time to get an alternative drug pre-authorized by the health plan.
CBER’s Product Shortage Coordinator The Product Shortage Coordinator within CBER’s Office of Compliance and Biologics Quality, Immediate Office of the Director, is the primary contact for potential or actual shortages of biologics regulated by CBER.
A Review of FDA’s Approach to Medical Product Shortage, October 31, 2011, available at http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ ucm275051.htm, accessed December 2011.
The CBER Product Shortage Coordinator is generally in close communication with other Department of Health and Human Services agencies, including the Biomedical Advanced Research and Development Authority (BARDA)27 and the CDC.
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage This guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.