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July 19, 2018
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
July 18, 2018
Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
July 12, 2018
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
July 10, 2018
Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
July 03, 2018
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
July 02, 2018
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
FDA seeks more efficient testing to spur development of less costly biotech therapies.