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TXT Suggestions for Elemental Impurities Draft Guidance [2637 Words] [ Price : $8.95]
Three stakeholders suggest changes to an FDA draft guidance on elemental impurities in drug products.
08/30/2016
 
 
TXT Guidance on Enforcement of NHRIC/NDC Device Codes [118 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.
08/30/2016
 
 
TXT Panel to Discuss Dynavax Hepatitis B Vaccine [93 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the Vaccines and Related Biological Products Advisory Committee 11/16 to discuss a Dynavax hepatitis B vaccine.
08/30/2016
 
 
TXT FDA Plans Small Business Device/Drug Education Conference [140 Words] [ Price : $8.95]
Federal Register Notice: CDER and CDRH plan a conference 9/27-28 entitled: “FDA Small Business and Industry Assistance Regulatory Education for Industry Fall Conference.”
08/30/2016
 
 
TXT Panel to Discuss 2 NDAs for Pneumonia [78 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the Antimicrobial Drugs Advisory Committee 11/4 to discuss two Cempra Pharmaceutical NDAs for treating bacterial pneumonia.
08/30/2016
 
 
TXT Latest FDA Warning Letters [830 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Amniotic Therapies, Brown’s Compounding Center, Central Admixture Pharmacy Services, Simpro, Vitalife Inc. dba Tabak’s Health Products, and Xinxiang Tuoxin Biochemical Co.
08/30/2016
 
 
TXT FDA Approves Sandoz Biosimilar for Enbrel Copy [1180 Words] [ Price : $8.95]
FDA approves a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgen’s Enbrel (etanercept).
08/30/2016
 
 
TXT FDA Accepts CSL Behring BLA for Hereditary Angioedema Attacks [1151 Words] [ Price : $8.95]
FDA accepts for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement therapy for preventing hereditary angioedema attacks.
08/30/2016
 
 
TXT FDA Finalizes Rule to Require Electronic Drug Registration/Listing [1216 Words] [ Price : $8.95]
FDA posts a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their registration and listing information.
08/30/2016
 
 
TXT Guidance on BE Recommendations for Risperidone [56 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Risperidone.
08/30/2016
 
 
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