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TXT FDA Moving Forward on Final Guide for Biosimilar Naming [357 Words] [ Price : $8.95]
FDA seeks OMB approval on the estimated burden for industry-proposed suffixes for biologic and biosimilar products.
06/01/2016
 
 
TXT FDAer on Responding to Data Integrity Warning Letters [2866 Words] [ Price : $8.95]
CDER’s Paula Katz gives tips on the best ways that drug companies can deal with data integrity issues.
06/01/2016
 
 
TXT Teva Gets Complete Response Letter for Huntington Drug [195 Words] [ Price : $8.95]
FDA issues Teva Pharmaceutical Industries a Complete Response Letter on its NDA for SD-809 (deutetrabenazine) tablets for treating chorea-associated Huntington disease.
06/01/2016
 
 
TXT Court Dismisses Health Science Funding Case vs. FDA [2735 Words] [ Price : $8.95]
The New Jersey federal court dismisses a case brought by Health Science Funding against FDA over the company’s Prastera that it sells as a dietary supplement for women with lupus.
06/01/2016
 
 
TXT FDA Approves Netspot Kit for Locating NET Tumors [257 Words] [ Price : $8.95]
FDA approves Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors.
06/01/2016
 
 
TXT FDA Accepts Radius Health NDA for Osteoporosis Therapy [145 Words] [ Price : $8.95]
FDA accepts for review a Radius Health NDA for abaloparatide-SC, indicated for treating postmenopausal women with osteoporosis.
06/01/2016
 
 
TXT Expedited Access Program Speeds New Devices: CDRH [2967 Words] [ Price : $8.95]
CDRH officials praise accomplishments in the first year of the Expedited Access Program.
06/01/2016
 
 
TXT CGMP Violations, Deviations in Corden Inspection [2807 Words] [ Price : $8.95]
FDA warns Italy’s Corden Pharma about CGMP violations and deviations in manufacturing finished pharmaceuticals and active pharmaceutical ingredients.
05/31/2016
 
 
TXT Updated Guidance on IDE Categorization [2656 Words] [ Price : $8.95]
FDA issues a guidance updating the framework it uses to categorize IDEs to assist the Centers for Medicare and Medicaid Services to make reimbursement decisions.
05/31/2016
 
 
TXT Megafine Pharma on Import Alert [2731 Words] [ Price : $8.95]
FDA warns India’s Megafine Pharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
05/31/2016
 
 
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