The FDA Just Called! Are You Ready for an Inspection?

If the FDA calls to schedule an  inspection, will you be prepared? by David R. Butcher Marketing Communications, MasterControl If the U.S. ...

FSMA: Get Inspection-Ready with These Best Practices

by Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group Although FDA immediately gained increased authority for records...

OMG! The FDA Is Keeping Up With Kim Kardashian, Too

The reality star promoted Diclegis on Instagram  without mentioning its side effects.  By Alex Butler, Product Manager, Life Science Applica...

Unique Device Identification (UDI): Much More Than Just a Label

Unique device identification (UDI) will not only change  the face of your med device labels, but it will  also affect processes spanning y...

FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

How are human cells, tissues and tissue-based products  (GCT/Ps) made from adipose  tissue regulated by the FDA? by Stacie L. Ropka  and Cha...

FDA Issues New Draft Documents Related to Compounding of Human Drugs

FDA has issued five draft documents related to  drug compounding that are applicable to pharmacies,  federal facilit...

Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Are you familiar with the draft guidance  on GMPs for combination products? by Suzanne M. O'Shea Counsel, Faegre Baker Daniels LLP Two ...