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Sources

 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) (astm.org)

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. https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.xml

4. FDA Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff. https://www.fda.gov/media/119958/download

5. FDA Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry. https://www.fda.gov/media/133676/download

6. FDA Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry. https://www.fda.gov/media/132043/download

7. European Medicines Agency (EMA) Guideline on the Quality Requirements for Drug-Device Combinations. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations_en.pdf

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. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424

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Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

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