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#Drug Quality

5 articles

Generic unbranded laboratory vials behind caution tape beside official-looking documents and a red inspection light.

FDA’s September 2026 Peptide Warning-Letter Sweep: What It Means

FDA posted warning letters to several peptide sellers on September 1. The letters focus on intended use, unapproved new drugs, misbranding, and injectable risks.

September 4, 2026 · 5 min

Three abstract molecular ribbon sculptures facing separate blank dossiers on a review table.

Peptides

FDA Reviews Semax, Epitalon, and DSIP-Related Bulk Substances

FDA’s July advisory presentation examined Semax, Epitalon, and Emideltide/DSIP-related bulk substances, emphasizing identity and evidence gaps.

August 30, 2026 · 5 min

Four generic molecular models on clear stands with blank evidence cards and a microscope.

Peptides

FDA Reviews BPC-157, KPV, TB-500, and MOTS-c for the 503A Bulks List

FDA’s July 2026 advisory review examined specific forms and uses of BPC-157, KPV, TB-500, and MOTS-c after their nominations were withdrawn.

August 30, 2026 · 5 min

Blank regulatory papers and folder arranged with a generic peptide model and glass paperweight.

Peptides

FDA Revises Generic Peptide Guidance: What the 17 Drafts Cover

FDA published 17 revised draft product-specific guidances for generic peptide development. Here is what they cover—and why they are not approvals.

August 30, 2026 · 5 min

Blank amber laboratory vials on an inspection tray with cargo containers in the background

Peptides

FDA’s GLP-1 Import Alert: What Changed for Bulk Drug Substances

FDA revised Import Alert 66-80 on August 21, allowing detention without physical examination of certain GLP-1 bulk drug substances while maintaining a compliance-based Green List.

August 29, 2026 · 5 min

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