Regulatory Briefs: CLIA Update; Product Reclassification; Thrombogenicity Workshop
This article was originally published in The Gray Sheet
Executive Summary
FDA provides a Clinical Laboratory Improvement Amendments administrative procedures guidance update. Absorbable lung biopsy plugs are reclassified. FDA will host a public workshop to discuss methods for thrombogenicity testing on April 14.
You may also be interested in...
Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program
According to an updated guidance on FDA’s eCopy submission program, it now accepts a broader range of PDFs. The update contains expanded guidelines for industry when submitting electronic versions of applications to FDA.
FDA Says Final CLIA Waiver Guidance Eases Burdens; Industry Isn’t Satisfied
Final guidelines to companies developing point-of-care diagnostic tests for use in less sophisticated laboratories offer more leeway in clinical trial design than FDA initially proposed
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.