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Info on Product Jurisdiction Sent to OMB

09/06/2016

Federal Register Notice: FDA’s proposed collection of information, “Product Jurisdiction: Assignment of Agency Compone...

FDA Determines 25 Drug Products Not Withdrawn for S&E

09/06/2016

Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reason...

FDA Establishes Antiseptic Ingredients Are Not GRAS/E

09/06/2016

Federal Register Final rule: FDA is issuing a final rule establishing that certain active ingredients used in over-the-counter (OT...

Guidance on Refuse to Receive ANDAs for Lack of Impurity Info

08/25/2016

Federal Register Notice: FDA is making available a guidance for industry entitled Abbreviated New Drug Application Submissions &md...

Guidance on Food for Animals CGMPs

08/25/2016

Federal Register Notice: FDA is making available a draft guidance for industry entitled Current Good Manufacturing Practice Requir...

Guidance on Human Food By-products Used for Animal Food

08/25/2016

Federal Register Notice: FDA is making available a draft guidance for industry entitled Human Food By-Products For Use As Animal F...

Guidance on Dietary Ingredient Notifications for Supplements

08/12/2016

Federal Register Notice: FDA is issuing a revised draft guidance for industry entitled Dietary Supplements: New Dietary Ingredient...

CBER Panel to Hear Research Updates

08/05/2016

Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee 9/7 from 1 p.m. to...

Workshop Planned on Pediatric Master Protocols

08/05/2016

Federal Register Notice: FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innov...

Mammography QA Committee to Meet

08/05/2016

Federal Register Notice: FDA will hold meeting 9/15 of the National Mammography Quality Assurance Advisory Committee. It will be h...