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Regulatory Focus Articles RSS Feed 2.0
30 July 2021
During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the US Food and Drug Administration’s (FDA) Oncolo...

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30 July 2021
The 26 July letter is the second issued by FDA for noncompliance with federal research reporting requirements outlined in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
30 July 2021
Two groups representing pharmaceutical manufacturers, wholesalers and distributors say they need more time to review draft guidance from the US Food and Drug Administration (FDA) calling for the establishment of electronic systems for tracking pro...
30 July 2021
Industry has argued that industry’s that medical devices cannot be compared to consumer electronics and are “categorically different than consumer goods in that they are heavily regulated products which have direct impact on patient care and safet...