Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

20 organizations filed 29 public comments on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, at the Food and Drug Administration. The comment window closed 3151d ago.

Abstract

Status: OPEN

Commenters (20)

• American Pharmacists Association (APhA)trade assoc.

  3 filings · confidence 97%
• National Association of Chain Drug Storestrade assoc.

  3 filings · confidence 97%
• National Community Pharmacists Associationtrade assoc.

  3 filings · confidence 97%
• Celgene Corporationunverified attribution

  2 filings · confidence 70%
• Healthcare Distribution Management Associationtrade assoc.

  2 filings · confidence 85%
• Pharmaceutical Care Management Associationtrade assoc.

  2 filings · confidence 85%
• American Academy of Dermatology Associationtrade assoc.

  1 filing · confidence 85%
• American Society of Health-System Pharmaciststrade assoc.

  1 filing · confidence 85%
• American Society of Hematologytrade assoc.

  1 filing · confidence 85%
• American Veterinary Medical Associationtrade assoc.

  1 filing · confidence 97%
• Baxter Healthcare Corporationunverified attribution

  1 filing · confidence 70%
• Bristol- Myers Squibb Companyunverified attribution

  1 filing · confidence 70%
• Generic Pharmaceutical Associationtrade assoc.

  1 filing · confidence 85%
• McKesson Corporationunverified attribution

  1 filing · confidence 70%
• National Association of Boards of Pharmacytrade assoc.

  1 filing · confidence 85%
• National Kidney Foundationtrade assoc.

  1 filing · confidence 85%
• Novartis Pharmaceuticals Corporationunverified attribution

  1 filing · confidence 70%
• Novartis Pharmaceuticals Corporation (NPC) - Supplementunverified attribution

  1 filing · confidence 70%
• Pfizer Inc.unverified attribution

  1 filing · confidence 70%
• Quintiles Transnational Corporationunverified attribution

  1 filing · confidence 70%