RE:RE:Drug/Device combination technology 1-2-3 June 2019 -
Theralase has a patented Study Drug and Study Device that when combined, have proven to be safe and effective in the treatment of patients inflicted with Bacillus Calmette Gurin-Unresponsive NMIBC. It's a FDA/CE category
May 2019 -
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
Johnson&Johnson also has similar concept ...
April 2019 ... https://pqri.org/wp-content/uploads/2019/04/1-PQRI-FDA-Conference-Day-1-Track-2-Session-3-Neadle.pdf
And you can also find more here:
The book will provide a thorough analysis of the fundamentals, applications and new technologies of drug-device combination products for use throughout the ...
30 nov. 2005 - The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach ...