FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

FDA has issued a draft guidance medical device  manufacturers should take to address cybersecurity risks. by Jason C. Gavejian, CIP P Princi...

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most  complex pharma track and trace law ever passed. by David Dills Sr. Consultant, Regulatory ...

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...

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Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Are you familiar with the draft guidance  on GMPs for combination products?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 ...

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

FDA issued a new draft guidance in 2013 on  the biological evaluation of medical devices. by Cheryl Wagoner Principal Consultant/Owner Wagon...