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Guidance on SPL Indexing

06/02/2008

Federal Register Notice: FDA is making available a guidance for industry, Indexing Structured Product Labeling. CBER and CDER will...

FDA OKs Lloyd Equine Pain Reliever

06/02/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Lloyd, Inc. ANADA for veterinary...

Mammography System into Class 2

05/30/2008

Federal Register Proposed rule: FDA is proposing to reclassify the full field digital mammography (FFDM) system from Class 3 (prem...

Comments Sought on PTCA Catheter Reclassification

05/30/2008

Federal Register Notice: FDA is seeking comments on the recommendation of the Circulatory System Devices Panel to reclassify Percu...

Skin Tissue Adhesives into Class 2

05/30/2008

Federal Register Final rule: FDA is reclassifying the device type, tissue adhesive for the topical approximation of skin, from Cla...

Comments Sought on Breast Cancer Ablation Trials

05/28/2008

Federal Register Notice: FDA is seeking comments on whether a registry could facilitate standardization of feasibility trials stud...

Panel to Discuss Ultrasound Contrast Agents

05/22/2008

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 6/24, from 8 a.m. to 5 p.m. at th...

Panels to Meet on Diabetes Drugs

05/22/2008

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 7/1, from 8 a.m. to 6 p.m. an...

FDA OKs Pfizer NADA for Skin Infections

05/22/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pfizer NADA for the veterinary p...

Guidance on Allogeneic Pancreatic Islet Cell Products

05/22/2008

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Considerations for Allogeneic Pancreatic...