Food and Drug Administration

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July 2026

Comment period closing · Food and Drug Administration · Jul 22Closed

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

Comment period closing · Food and Drug Administration · Jul 22Closed

Citizen Petition from Apotex Inc.

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

Upcoming deadlines

Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments

Comment closes · Oct 27

Suitability Petition from Hyman, Phelps, & McNamara P.C.

Comment closes · Nov 25

FDA Rare Disease Innovation Hub Future Programming; Request for Comments

Comment closes · Jan 1

Data Request (DR001): Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use

Comment closes · Jan 26

Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

Comment closes · Dec 2

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