英文真的很重要，继续学习！
FDA's role in the management of drug shortages has changed in recent years, the Food and Drug Administration Safety and Innovation Act also known as FDASIA was passed by Congress in 2012 and provides new authorities for FDA to manage drug shortages药物短缺.
This is drug info药物信息 rounds brought to you by the pharmacist药剂师 in the FDA's division of drug Information FDA药物信息部门.
Advanced notification to FDA of a potential drug shortage or disruption in supply is essential. Without early warning, FDA can't engage with the manufacturer and other stakeholders to begin to address this shortage and maybe even prevent it prior to pate as a mandatory notification to FDA of a potential drug shortage or disruption in supply was limited. Among other things that you brought in the scope of early notification Which greatly improves F d's ability to manage shortages.
Will you give us more details about F D a as IA?
One of the most significant changes in fdafia related to drug shortages is the expanded scope of the early notification. Most significant changes in fidelity are related to drug shortages is the expanded scope of the early notification requirements. For example, fidelity requires manufacturers to report to fga both permanent discontinuance of certain critical drugs as well as temporary interruptions in manufacturing that may lead to a shortage. The prior law only required reporting of discontinuance . Fdasia Also requires all the manufacturers of these critical drugs to notify FDA of discontinuance or Interruptions in manufacturing . The Prior law applied Law applied only to sole source manufacturers. In addition, fidelity enables FDA to require mandatory reporting of discontinuance or interruptions in manufacturing of biological products. The prior law excluded all biological products from reporting requirements finally, fidelity requires FDA to issue a public non compliance letter to manufacturers who failed to comply with the early notification requirements. The prior laws did not include any enforcement mechanism for early notification.
In addition to the changes to the early notification requirements, facility also requires FDA to provide congress with an annual report on drug shortages and a strategic plan.
Let's remind pharmacists that these new requirements complement FDA activities to mitigate drug shortages that were in place prior to Fdasia.
When FDA They learns of a potential shortage. The agency may use several different tools to prevent or mitigate the shortage. For example, FDA may work with sponsors to resolve manufacturing or quality issues that may be causing the shortage. Expedite its pectoral, evie ate the shortage. I dent of ire Turner tive manufacturers who are willing to initiate or increased production of the drug in shortage approving and provide regulatory discretion for the temporary importation of a non us product after During the drug does not pose undue risks for us patients and ensure it is manufactured in a facility that meets FDA quality standards.
网友评论