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 1. New Guide for Standard Guide for Definition of Combination Products (Drug/Device/Biologic Combinations). ASTM International. WK72293 New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations) (

2. Roan S. Strategies for Using a Common Injector Technology for Multiple Drug Products: Regulatory, Change Management and Design Control Considerations. PDA Combination Products Workshop, October 2020

3. 21st Century Cures Act.

4. FDA Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff.

5. FDA Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry.

6. FDA Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry.

7. European Medicines Agency (EMA) Guideline on the Quality Requirements for Drug-Device Combinations.

8. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

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Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

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