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New harmonised guidance for post-approval changes released by FDA
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The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
The US Food and Drug Administration (FDA) has released its final guidance for industry with new International Council for Harmonisation (ICH) guidelines, providing a more predictable and efficient framework for the management of post-approval chemistry, manufacturing and controls changes.
According to the FDA, the recommendations discuss how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval.
How To Use DMF Content To Support Your Application To The FDA
By S. D. Devendra Raj, Ph.D., Freyr
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA at the discretion of the DMF holder to assist its customers. A DMF is used to provide confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing one or more active pharmaceutical ingredients (APIs) and/or human drugs in the absence of relevant information about the drug substance, drug product, and/or container closure. A DMF is not an alternate regulatory submission for an IND, an (NDA, an ANDA, another DMF, an export application, or amendments and supplements to any of the mentioned, but can be used to support these applications.
FDA Keynote Speakers at SMi s 4th Annual Pharmaceutical Microbiology East Coast Virtual Conference in 3 weeks einnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from einnews.com Daily Mail and Mail on Sunday newspapers.
FDA Inspections: Are Changes On The Horizon?
By Kalah Auchincloss, SVP & deputy general counsel, Greenleaf Health, Inc.
Almost exactly one year ago, in March 2020, the U.S. FDA announced that it was suspending all foreign and domestic inspections except those it deemed “mission critical.”[1] This unusual move was a response to the then-emerging COVID-19 pandemic an attempt to reduce transmission of the virus and protect both FDA personnel and industry employees.
Even as it suspended inspections, the agency assured the public that it had “full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.”[2] A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply.