FDA's Draft Guidance Pediatric Uses of Medical Devices

Sunday, March 2, 2014 10:36:45 AM Europe/Berlin

The Food and Drug Administration (FDA) is issuing a final rule amending the

regulations on premarket approval of medical devices to include requirements relating to the

submission of information on pediatric subpopulations that suffer from the disease or condition that

a device is intended to treat, diagnose, or cure.


See --> Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

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