Food and Drug Administration

FDA

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July 2026

Comment period closing · Food and Drug Administration · Jul 28Closed

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)

Comment period closing · Food and Drug Administration · Jul 28Closed

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry

Notice · Food and Drug Administration · Jul 28

Partial Response

Notice · Food and Drug Administration · Jul 28

Acknowledgment Letter from FDA DMB to Hyman, Phelps & McNamara, P.C.

Notice · Food and Drug Administration · Jul 28

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

Notice · Food and Drug Administration · Jul 28

Attachment 1 - Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations

Notice · Food and Drug Administration · Jul 28

Acknowledgement Letter from FDA DMB to Lachman Consultant Services, Inc.

Notice · Food and Drug Administration · Jul 28

Suitability Petition from Lachman Consultant Services, Inc.

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Variance Approval Letter to Alexander Hilbert

Notice · Food and Drug Administration · Jul 28

Variance Application from Alexander Hilbert

Notice · Food and Drug Administration · Jul 28

Interim Response from FDA CDER to Alexander Mauskop

Notice · Food and Drug Administration · Jul 28

Notice · Food and Drug Administration · Jul 28

Attachment 3 - Draft Package Insert Proposed for Bupivacaine Hydrochloride and Epinephrine Bitartrate Injection

Upcoming deadlines

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings

Comment closes · Aug 6

Medical Device User Fee Amendments; Public Meeting; Request for Comments

Comment closes · Aug 8

Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA

Comment closes · Aug 13

Development of 21st Century Cures Act Section 3060 Required Report: Request for Input

Comment closes · Aug 14

Forms FDA 3542a and FDA 3542: Questions and Answers; Guidance for Industry

Comment closes · Aug 15

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