Accelerated Approval Labeling Changes Take Shape In Recent Approvals
FDA has started implementing changes called for in a draft guidance on labeling of drugs granted accelerated approval throughout the last three-quarters of 2014, without waiting for the final guidance or even the comment period to close.
You may also be interested in...
Accelerated Approval: US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing ‘Additional Context’
For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate; however, labeling for other types of drugs may need to reflect the clinical outcomes that are expected but not yet established, agency says.
Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient
In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.
GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals
From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.