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Welcome to FDAweb Pay Per View Search our 45,601 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   Standard Approach Sought for Immunosuppressant NDAs [189 Words] [ Price : $7.95] The Skadden Arps law firm asks FDA to maintain a 12-month clinical trial standard for NDAs for new, modified, or reformulated primary or adjunctive immunosuppressants for kidney transplant patients. 05/09/2013     2 Draft Investigational Drug Guidances Out [137 Words] [ Price : $7.95] FDA releases draft guidances on expanded access to investigational drugs for treatment uses and charging for investigational drugs under an IND. 05/09/2013     Per Capita Spending on Medicines Down 3.5% [109 Words] [ Price : $7.95] An IMS report says total spending on U.S. medicines was $325.8 billion in 2012, down 3.5% from the previous year. 05/09/2013     Warner Chilcott New Contraceptive Approved [95 Words] [ Price : $7.95] FDA approves a Warner Chilcott NDA for its new oral contraceptive, norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets. 05/09/2013     Former FDA Orphan Drug Head Joins Emmaus Medical [187 Words] [ Price : $7.95] Former FDA Office of Orphan Product Development director Timothy Cote joins Emmaus Medical to help the company on its regulatory pathway for the company's sickle cell disease treatment. 05/09/2013     RegenKit-THT Being Marketed for Unapproved Uses: CBER [200 Words] [ Price : $7.95] CBER says Montreal’s Regenlab America is marketing its RegenKit-THT for unapproved cosmetic surgery indications. 05/09/2013     Guidance on Investigational Drug Expanded Access [87 Words] [ Price : $7.95] Federal Register Notice: FDA releases a draft guidance, Expanded Access to Investigational Drugs for Treatment Use — Qs & As. 05/09/2013     Guidance on Charging for Investigational Drugs Under an IND [67 Words] [ Price : $7.95] Federal Register Notice: FDA releases a draft guidance, Charging for Investigational Drugs Under an IND — Qs & As. 05/09/2013     FDA Proposes to Reclassify UV Sun Lamps into Class 2 [80 Words] [ Price : $7.95] Federal Register Proposed order: FDA proposes to reclassify ultraviolet lamps intended to tan the skin from Class 1 to Class 2 (special controls) and subject to premarket notification. 05/09/2013     Meeting on Generic Drugs Initiatives [111 Words] [ Price : $7.95] Federal Register Notification: FDA plans a public meeting 6/21 on regulatory science initiatives for generic drugs. 05/09/2013     << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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