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TXT FY 2015 Prescription Drug User Fees Set [65 Words] [ Price : $8.95]
Federal Register Notice: FDA announces the rates for prescription drug user fees for fiscal year 2015.
08/01/2014
 
 
TXT Comments Sought on Tobacco Data Info [45 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a collection of information on qualitative data on tobacco products.
08/01/2014
 
 
TXT Comments Sought on Fast-Track Designation Requests [68 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on sponsor requests for fast track designation.
08/01/2014
 
 
TXT FDA Drug and Device Import Refusals Up: Consultants [244 Words] [ Price : $8.95]
Registrar Corp. says FDA is increasing enforcement against non-registered drug and medical device manufacturers and unlisted or unapproved drugs.
07/31/2014
 
 
TXT Final Guidance on Companion Diagnostic Devices [339 Words] [ Price : $8.95]
FDA releases a final guidance on In Vitro Companion Diagnostic Devices that is intended to help companies identify the need for these tests during the earliest stages of drug development.
07/31/2014
 
 
TXT FDA Approves BIís Striverdi Respimat for COPD [261 Words] [ Price : $8.95]
FDA approves Boehringer-Ingelheimís Striverdi Respimat for treating patients with chronic obstructive pulmonary diserase.
07/31/2014
 
 
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FDA is asked to consider changes to a draft guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference product.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FDA says it will soon publish a draft guidance on laboratory-developed tests that will outline a risk-based oversight framework.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
 
 
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