HeyJaredKate Hardey
- Indexed articles, last 90 days
- 3
- Latest publication
- Aug 3, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 14, 2026
Latest articles
FDA Advisory Committee Recommends Six Peptides For Compounding: What The Evaluation Criteria Tell Us About The Road Ahead (opens the original)
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On July 23 and 24, the Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee (PCAC or Committee) convened for a closely watched two-day meeting to evaluate whether seven peptides should be recommended for inclusion on the list of bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (503A Bulks List). The peptides were reviewed in both free base and acetate salt forms. Despite FDA’s scientific review team’s oppo
Drawing The Device Line: FDA Seeks Public Input On Patient Safety And Non-Device Health Software (opens the original)
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On July 14, the U.S. Food and Drug Administration (FDA) announced it is seeking public input regarding the patient safety impacts of certain medical software functions excluded from the definition of a medical device under the 21st Century Cures Act. In particular, the FDA is requesting input on best practices to promote patient safety, education, and competency associated with these non-device software functions. Comments are due August 13, 2026. The statutory definition of a medical device und
FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing And Foreign API Registration Changes Could Mean For Pharma Compliance (opens the original)
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In the wake of the Food & Drug Administration’s (FDA) ambitious unified agenda, on July 13, 2026, the agency published a proposed rule aiming to align its regulatory frameworks with “how distributed manufacturing actually works.” The proposed rule would create a tailored drug establishment registration framework for certain distributed manufacturing establishments (DMEs) and clarify the registration and listing obligations applicable to certain foreign drug establishments. The proposed rule is i
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