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TXT Hospira Recalls Hemoset Dual Channel Plum Set [272 Words] [ Price : $8.95]
FDA says Hospira is recalling two lots of Hemoset Dual Channel Plum Sets that could result in over-delivery of blood or blood products.
03/18/2014
 
 
TXT CDRH Draft Guidance on HDE Submissions [78 Words] [ Price : $8.95]
CDRH posts a draft guidance entitled “Humanitarian Device Exemption: Questions and Answers.”
03/17/2014
 
 
TXT FDA Approves Pierre Fabre NDA for Hemangeol [100 Words] [ Price : $8.95]
FDA approves a Pierre Fabre Dermatologie NDA for Hemangeol (propranolol hydrochloride), indicated for treating proliferating infantile hemangioma.
03/17/2014
 
 
TXT Edison Pharma Fast Track for Friedreich’s Ataxia Drug [136 Words] [ Price : $8.95]
FDA grants Edison Pharmaceuticals fast track status for EPI-743 for treating Friedreich’s ataxia.
03/17/2014
 
 
TXT CDER Posts New BA/BE Draft Guidance [132 Words] [ Price : $8.95]
CDER posts a new draft guidance entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.”
03/17/2014
 
 
TXT Attorneys Warn on Internal Corp. Compliance Investigations [242 Words] [ Price : $8.95]
Reed Smith lawyers caution that medical product manufacturers should review procedures relating to internal corporate compliance program investigations to make sure they will be protected and privileged communications.
03/17/2014
 
 
TXT FDA Panel Backs Starr Surgical Eye Implant [126 Words] [ Price : $8.95]
FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee recommends expanded approval for Staar Surgical’s Visian Toric implantable collamer lens for treating myopia and astigmatism.
03/17/2014
 
 
TXT OMB OKs Info on Minor Use/Species New Animal Drugs [51 Words] [ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on designation of new animal drugs for minor use or minor species.
03/17/2014
 
 
TXT FDA to Change NADA Disclosure Rules [86 Words] [ Price : $8.95]
Federal Register Proposed rule/direct final rule: FDA amends the animal drug regulations to change when certain data/information in new animal drug application would be disclosed.
03/17/2014
 
 
TXT Amgen Reports Positive TESLA Phase 3 Results [194 Words] [ Price : $8.95]
Amgen says its Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab has met its primary endpoint.
03/17/2014
 
 
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