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# Comments on Drug Shortage Risk Guidance
- URL: https://www.fdaweb.com/comments-on-drug-shortage-risk-guidance/
- Published: 2022-08-17T12:00:00.000Z
- Updated: 2026-09-14T17:56:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152529

Becton Dickinson says additional clarification is needed in an FDA draft guidance on risk management plans (RMPs) to mitigate the potential for drug shortages. The clarification [sought](https://www.regulations.gov/comment/FDA-2022-D-0277-0015?ref=fdaweb.com) involves which components of a product need to be incorporated into a risk management plan, particularly in the case of device constituent components for combination products. BD says the draft “does not provide enough detailed examples or information about content needed in a risk management plan for combination products.”

In its [letter](https://www.regulations.gov/comment/FDA-2022-D-0277-0014?ref=fdaweb.com), the HealthCare Institute of New Jersey, a trade association for the state’s research-based biopharmaceutical and medical device companies, recommends specific revisions “to ensure that the guidance can provide a responsive framework for drug and device companies and their suppliers in developing RMPs.”