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

RIN

—

Last modified

Jun 26, 2026

Comment window

closes in 2d

National Association of Manufacturers (NAM) filings

Activity

National Association of Manufacturers (NAM) filed 1 comment on this docket between Jul 24, 2026 and Jul 24, 2026. 28 other organizations filed here. The comment window closes in 2d.

What National Association of Manufacturers (NAM) filed (1)

Jul 24, 2026· Comment from National Association of Manufacturers· FDA-2018-N-3240-3318

The National Association of Manufacturers (NAM) appreciates the opportunity to submit the attached comments in response to FDA's evaluation of "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act".

Download attachment ↓View on regulations.gov →

Abstract

No abstract recorded.

View on regulations.gov →

Co-filers (28)

See everyone who commented →

National Association of Manufacturers (NAM)THIS ORG
1 filing · confidence 97%
Outsourcing Facilities Associationtrade assoc.
10 filings · confidence 85%
American Association of Clinical Endocrinologytrade assoc.
2 filings · confidence 85%
Black Hills Regional Eye Institutetrade assoc.
2 filings · confidence 85%
American Medical Associationtrade assoc.
1 filing · confidence 97%
American Vein & Lymphatic Society/American Venous Forumtrade assoc.
1 filing · confidence 85%
Amneal Pharmaceuticals LLCunverified attribution
1 filing · confidence 70%
Arnall Golden Gregory LLPunverified attribution
1 filing · confidence 70%
Eating Disorders Education Institutetrade assoc.
1 filing · confidence 85%
Florida Osteopathic Medical Associationtrade assoc.
1 filing · confidence 85%
Health Equity Coalition for Chronic Diseasetrade assoc.
1 filing · confidence 85%
LLC ("Athenex")unverified attribution
1 filing · confidence 70%
Missouri Phlebology Incunverified attribution
1 filing · confidence 70%
Mobius Therapeutics LLCunverified attribution
1 filing · confidence 70%
National Consumers Leaguetrade assoc.
1 filing · confidence 85%
Nephron Pharmaceutical Corporationunverified attribution
1 filing · confidence 70%
Ohio Phlebology Professional Corporationunverified attribution
1 filing · confidence 70%
Oregon Consumer Leaguetrade assoc.
1 filing · confidence 85%
Outsourcing Facility Associationtrade assoc.
1 filing · confidence 85%
Pacific Research Institutetrade assoc.
1 filing · confidence 85%
PD Science LLCunverified attribution
1 filing · confidence 70%
PharMEDium Services LLCunverified attribution
1 filing · confidence 70%
Society of Interventional Radiologytrade assoc.
1 filing · confidence 85%
SterRx LLCunverified attribution
1 filing · confidence 70%
Texas Conservative Coalition Research Institutetrade assoc.
1 filing · confidence 85%
The Alliance for Safe Biologic Medicinestrade assoc.
1 filing · confidence 85%
The Compounding Quality Coalitiontrade assoc.
1 filing · confidence 85%
WA State Obesity Societytrade assoc.
1 filing · confidence 85%
Washington Obesity Societytrade assoc.
1 filing · confidence 85%