News Publications

Our QuickNotes provide you with a quick summary of relevant topics.

The GMP Gazette™ December 2017

  • Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times
  • Notice: Publication of the Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing

FDA Dietary Supplement cGMP

The Food and Drug Administration (FDA) has issued a final rule regarding current good manufacturing practices (cGMP) for dietary supplements that establishes the minimum requirements for manufacturing, packaging, labeling or holding of dietary supplements to ensure that products meet appropriate quality standa