EN PL
  1. www.sciencepharma.com
  2. News
  3. FDA
  4. FDA: Guidance for Industry and FDA Staff: - Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

FDA: Guidance for Industry and FDA Staff: - Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

05.09.2013
This guideline addresses specific application systems with regard to combination products. The guideline deals with aspects relevant for a marketing authorisation and expected by the FDA in a submission.
The source of the news: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf