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TXT ICH Guidance on Veterinary Drug Residues in Human Food [125 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose.
06/01/2015
 
 
TXT Guidance on Drug/Biologic Reportable CMC Changes [132 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.
06/01/2015
 
 
TXT Patient-Focused Meeting on Alpha-1 Antitrypsin Deficiency [130 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 9/29 on patient-focused drug development for Alpha-1 Antitrypsin Deficiency.
06/01/2015
 
 
TXT Groups Support New Standards for Nanotechnology Drugs [526 Words] [ Price : $8.95]
Comments from two groups support the need for FDA to establish more comprehensive, stringent and appropriate standards and guidelines for approving cancer drugs using nanotechnology.
06/01/2015
 
 
TXT FDA Posts Draft Guide on Reportable CMC Changes [490 Words] [ Price : $8.95]
FDA posts a draft guidance on “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.”
05/29/2015
 
 
TXT Merck Submits NDA for Chronic Hepatitis C Genotypes [91 Words] [ Price : $8.95]
Merck submits an NDA for grazoprevir/elbasvir (100mg/50mg) for treating adults with chronic hepatitis C genotypes 1, 4 or 6 infection.
05/29/2015
 
 
TXT FDA Approves Rapamune for Lymphangioleiomyomatosis [189 Words] [ Price : $8.95]
FDA approves Wyeth Pharmaceuticals’ Rapamune (sirolimus) for treating lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age.
05/29/2015
 
 
TXT OMB OKs Info AERs During Influenza Pandemic [54 Words] [ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a FDA collection of information on postmarketing adverse event reporting for medical products/supplements during an influenza pandemic.
05/29/2015
 
 
TXT Appeals Court Requires Namenda IR to Remain on Market [299 Words] [ Price : $8.95]
A just-published opinion from the 2nd Circuit Court of Appeals upholds a 12/2014 district court preliminary injunction requiring Actavis to continue distribution of Namenda (memantine HCl) immediate-release tablets.
05/29/2015
 
 
TXT Info on Drug/Biologic Labeling Sent to OMB [55 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on requirements on content and format of drug and biologic labeling.
05/29/2015
 
 
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