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FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

November 17, 2017

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance

September 20, 2017

FDA Seizes Stem Cell Therapy—A First of Many?

August 29, 2017

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

July 20, 2017

To certify or not to certify? FDA has answered the question

June 13, 2017

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

September 22, 2016

NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016

March 28, 2016

FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

February 23, 2015

FDA Announces Enforcement Discretion in Implementing the DSCSA’s Product Tracing Requirements, Delaying Enforcement until May 1, 2015

December 29, 2014

FDA Issues Two Proposed Guidance Documents For Laboratory Developed Tests

August 25, 2014

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