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TXT FDA Re-inspects Hospira Rocky Mount Facility with 0 Findings [459 Words] [ Price : $8.95]
Hospira says its troubled Rocky Mount, NC manufacturing facility was recently re-inspected and it resulted in no inspectional observations.
07/31/2014
 
 
TXT Changes Sought in Clinical Pharmacology Guidance [401 Words] [ Price : $8.95]
FDA is asked to consider changes to a draft guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference product.
07/31/2014
 
 
TXT FDA Proposes Risk-based Framework for Lab-developed Tests [410 Words] [ Price : $8.95]
FDA says it will soon publish a draft guidance on laboratory-developed tests that will outline a risk-based oversight framework.
07/31/2014
 
 
TXT FDA Posts June NADA, ANADA Approvals [91 Words] [ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflects June approval actions for NADAs and ANADAs.
07/31/2014
 
 
TXT Validated Software for Better Compliance: Consultants [285 Words] [ Price : $8.95]
GxP-CC Consultants says that companies may benefit from validated compliance software to provide more uniform oversight over electronic records and signatures.
07/31/2014
 
 
TXT Some Generic Drug User Fees will Fall in FY 2015 [162 Words] [ Price : $8.95]
FDA says that generic drug user fees for fiscal year 2015 (beginning 10/1) will fall significantly for ANDA, prior approval supplement, and drug master file submissions.
07/31/2014
 
 
TXT Regeneron, Sanofi Using Voucher for Alirocumab Review [303 Words] [ Price : $8.95]
Regeneron and Sanofi buy a rare pediatric disease priority review voucher from BioMarin for use with an alirocumab BLA.
07/31/2014
 
 
TXT FDA Panel Backs Baxter’s HyQvia [147 Words] [ Price : $8.95]
FDA’s Blood Products Advisory Committee votes 15 to 1 to recommend approval of Baxter International’s HyQvia, indicated for treating patients with primary immunodeficiency.
07/31/2014
 
 
TXT Drug Development Tool Qualification Program MAPP [257 Words] [ Price : $8.95]
CDER issues a MAPP with policies, responsibilities, and procedures for drug development tool qualification programs.
07/30/2014
 
 
TXT CDER Issues ‘Breakthrough’ Drug MAPP [259 Words] [ Price : $8.95]
CDER issues a Manual of Policies and Procedures on its actions to expedite development and review of breakthrough therapy-designated INDs.
07/30/2014
 
 
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