FDA's Pre-Sub replaces pre-IDE

Sunday, March 2, 2014 10:25:47 AM Europe/Berlin

Established in 1995, the pre-IDE program has been a successful resource for both medical device applicants and FDA and has become the most commonly used mechanism for requesting FDA’s feedback prior to a premarket device submission.

Intentially, this program was designed to provide applicants a tool to obtain FDA feedback on planed IDE applications prior to their submission. This new guidance ioncludes a broader scope of the program.


See --> Requests for Feedback on Medical Device Submissions. The Pre-Submission Program and Meetings with FDA

Posted By QM-Docs

FDA announced new Guidance Docs for 2011

Thursday, March 17, 2011 9:59:32 PM Europe/Berlin

FDA CDER announced new Guidance Agenda to be update existing Guidance regulations or to publish new Guidance in calendar year 2011.

There are a number of really interesting topics on the agenda like:

  • Bioanalytical Methods Validation
  • Development of Drugs in Combination
  • Contract Manufacturing
  • Control of Components
  • Control of Highly Potent Compounds
  • Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
  • Medical Gases, General CGMP
  • Non-Penicillin Beta-Lactam Contamination 
  • Outsourcer Pharmacy Operations Compliance Policy Guide
  • Pharmaceutical Component Quality Control
  • Pharmaceutical Manufacturing Statistics
  • Prevention and Control of Viral Contamination
  • Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat 
  • Good Pharmacy Compounding Practices for Sterile Drug Products

See the full agenda on the CDERs Homepage.

Posted By QM-Docs