Tag

cder
For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  
Read More
The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures Act
Read More
http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm
Read More
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdf
Read More
http://www.fda.gov/cder/regulatory/ersr/FDARegional/ectd.htm
Read More

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.