When It Comes To Sponsor Meetings, FDA Is Getting A ‘D’
New ‘Type D’ meetings will be added as part of PDUFA VII, one of a spate of changes under the next version of the user fee program that will begin in October 2022.
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Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill
Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.
Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes
Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.
One-Page Patient Medication Information Document Moves Forward Under Proposed Rule
After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.