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FDA Approves Two Alpharma sNADAs

01/14/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two supplemental new animal drug a...

Comments Sought on Med Guide Regs

01/12/2005

Federal Register Notice: FDA is seeking public comment on regulations requiring the distribution of patient labeling, called Medic...

OMB OKs Presubmission Conference Info

12/14/2004

Federal Register Notice: FDA’s collection of information entitled “Presubmission Conference” has been approved b...

Comments Sought on Corrections/Removals Reports

12/14/2004

Federal Register Notice: FDA is seeking public comment on information collection requirements for reports of corrections and remov...

Comments Sought on Device Labeling Regs

12/14/2004

Federal Register Notice: FDA is seeking public comment on medical device labeling regulations — 21 CFR Parts 800, 801, and 8...

FDA OKs Phoenix Scientific Canine Edema ANADA

12/14/2004

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an abbreviated new animal drug app...

FDA Seeks Comments on Fast Track Designation Info

12/13/2004

Federal Register Notice: FDA is seeking public comment on the proposed collection of information on sponsor requests for fast trac...

FDA Proposes Exempting Categories from Environmental Impact Regs

11/24/2004

Federal Register Proposed rule: FDA is proposing to amend its regulation on environmental impact considerations to expand existing...

Guidance on Newborn Screening Test Systems

11/24/2004

Federal Register Final rule, Notice: FDA is classifying newborn screening test systems for amino acids, free carnitine, and acylca...

FDA Publishes Streptogramin Risk Assessment

11/24/2004

Federal Register Notice: FDA is making available a draft risk assessment of the potential impact that food-animal use of streptogr...