Food and Drug Administration

FDA

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July 2026

Notice · Food and Drug Administration · Jul 22

Reference 10 - FDA, ''Technical Considerations for Additive Manufactured Medical Devices" (December 2017)

Notice · Food and Drug Administration · Jul 22

Reference 9 - Nano-silver/carbon nanotube composite coatings on airway stents (Sci Rep 2025; open access)

Notice · Food and Drug Administration · Jul 22

Reference 8 - Kostov KG, et al. Plasma Surface Modification of the Inner Wall of Montgomery's Tracheal Implant (Polymers 2024; open access)

Notice · Food and Drug Administration · Jul 22

Reference 7 - FDA 51 0(k) Summary: Patient-Specific Airway Stent (K 182743)

Notice · Food and Drug Administration · Jul 22

Reference 6 - FDA Custom Device Exemption Guidance (September 2014)

Notice · Food and Drug Administration · Jul 22

Citizen Petition from Cheol Ho Song

Notice · Food and Drug Administration · Jul 22

Completeness Assessment Correspondence

Notice · Food and Drug Administration · Jul 22

Notice · Food and Drug Administration · Jul 22

Notice · Food and Drug Administration · Jul 22

Memorandum re Drug Establishment Registration (Proposed Rule)

Notice · Food and Drug Administration · Jul 22

Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.

Notice · Food and Drug Administration · Jul 22

Final Response Letter from FDA CDER to APDM Pharmaceuticals Private Limited

Notice · Food and Drug Administration · Jul 22

TAB C-2023-173-Drug Establishment-Proposed Rule-Final

Notice · Food and Drug Administration · Jul 22

TAB C-2023-173-Drug Establishment-PRIA-Final

Notice · Food and Drug Administration · Jul 22

TAB B-2023-173-Drug Establishment-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL

Notice · Food and Drug Administration · Jul 22

TAB B-2023-173-Drug Establishment-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL

Notice · Food and Drug Administration · Jul 22

TAB A-2023-173-Drug Establishment-Proposed Rule-Original

Notice · Food and Drug Administration · Jul 22

TAB A-2023-173-Drug Establishment-PRIA-Original

Notice · Food and Drug Administration · Jul 22

Response Letter from FDA CDER to American Cleaning Institute

Notice · Food and Drug Administration · Jul 22

Acknowledgment Letter from FDA DMB to Bryan Smith

Upcoming deadlines

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species

Comment closes · Jul 30

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

Comment closes · Jul 30

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Comment closes · Jul 31

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Comment closes · Aug 1

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products

Comment closes · Aug 1

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