FDA Policy Changes on Stability Studies for PET Drugs Manufactured Within Networks
TO THE EDITOR: During the process of developing a new PET drug and obtaining marketing authorization from the Food and Drug Administration (FDA), the stability of a product is assessed to ensure that the purity and quality meet (or exceed) specifications at both the time of release and expiration.
Authors
- Michael Nazerias
- Ashley Mishoe
- Steven S. Zigler
- Henry F. VanBrocklin (ORCID: https://orcid.org/0000-0003-2849-0841)
- Christopher Ignace
- Peter J. H. Scott
- D. Christian Parr
- Hsiaoju S. Lee
Publication Details
- Journal
- Journal of Nuclear Medicine
- Published
- 2026-10-15
- DOI
- https://doi.org/10.2967/jnumed.126.274002
- Primary Topic
- Radiopharmaceutical Chemistry and Applications
- Type
- article
- Field-Weighted Citation Impact
- 0.00