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CDER/CBER Push 3.2 Version of E-Data Interchange Standards

08/18/2015

Federal Register Notice: CBER and CDER are announcing support for the 3.2 version of Clinical Data Interchange Standards Consortiu...

Participants Sought for MDR Malfunctions Pilot

08/18/2015

Federal Register Notice: FDA is soliciting nominations for participation in a pilot program for submitting medical device reports ...

Esophageal Device into Class 2

08/18/2015

Federal Register Final order: FDA is classifying the esophageal thermal regulation device into Class 2 (special controls). The spe...

FDA Corrects Notice on Quality Metrics Guidance

08/07/2015

Federal Register Notice: FDA is correcting a notice from the 7/28 Federal Register on a draft guidance for industry entitled Reque...

FDA Corrects Notice on Tobacco Product Applications

08/07/2015

Federal Register Notice: FDA is correcting a 7/31 Federal Register notice that reopened the period for public comment on modified ...

Guidance on Nanomaterials in Animal Food

08/05/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Use of Nanomaterials in Food for Animals. It is ...

Guidance on OTC Pediatric Acetaminophen Liquid Drugs

08/05/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Over-the-Counter Pediatric Oral Liquid Drug Prod...

Tissue Marker into Class 2

08/05/2015

Federal Register Final order: FDA is classifying the internal tissue marker into Class 2 (special controls). The special controls ...

Guidance on Stability Testing for New Veterinary Drugs

07/31/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Bracketing and Matrixing Designs for Stability T...

Comments Re-opened on Modified Risk Tobacco Products

07/31/2015

Federal Register Notice: FDA is reopening the period until 8/31 for public comment on modified risk tobacco product applications (...