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June 2, 2023
This guidance describes the mechanisms available through which submitters can request FDA feedback regarding potential or planned medical device submissions.
June 2, 2023
Pharmacology / Toxicology
June 1, 2023
This guidance presents the background and rationale for FDA’s action level for inorganic arsenic in apple juice.
May 25, 2023
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.
May 25, 2023
Guidance for recommendations for manufacturers to meet special controls for non-clinical performance of laparoscopic power morcellation containment systems.
May 25, 2023
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
May 25, 2023
On Wednesday, May 24, 2023, the Oversight & Investigations Subcommittee of the House Committee on Natural Resources held a hearing titled “Examining the Biden Administration’s Efforts...
May 18, 2023
This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S.