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TXT PTC Therapeutics Completes NDA Submission for Duchenne [106 Words] [ Price : $8.95]
PTC Therapeutics completes rolling submission of an NDA for its nonsense mutation Duchenne muscular dystrophy agent Translarna (ataluren).
01/08/2016
 
 
TXT Guide on ‘Emerging Signals’ Has Unintended Consequences: Attorney [516 Words] [ Price : $8.95]
Reed & Smith attorney James Beck says FDA’s draft guidance on Public Notification of Emerging Postmarket Medical Device Signals could have unintended consequences that may encourage medical device and drug companies to engage in more off-label promotions and may lead to more unfounded product liability lawsuits.
01/08/2016
 
 
TXT Comments Extended on Sunscreen Guidance [44 Words] [ Price : $8.95]
Federal Register Notice: FDA extends the comment period on a draft guidance on safety and effectiveness data for OTC sunscreens.
01/08/2016
 
 
TXT Guidance on Hepatitis B Tests for HCT/P Donors [152 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of HCT/P-Based Products.
01/08/2016
 
 
TXT Panel to Discuss Fecal Incontinence Device [188 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 2/25 to vote on a PMA for the TOPAS Treatment for Fecal Incontinence.
01/08/2016
 
 
TXT CDER Policy on Drug Proprietary Name Reviews [233 Words] [ Price : $8.95]
CDER posts a revised internal procedure document on handling requests for drug proprietary name reviews.
01/08/2016
 
 
TXT CBER Guidance on Hep B Testing for Cell/Tissue Donors [138 Words] [ Price : $8.95]
CBER posts a draft guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.”
01/07/2016
 
 
TXT Workshop on GMPs for Hearing Aids [93 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 4/21: “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.”
01/07/2016
 
 
TXT FDA OKs Integra Omnigraft for Diabetic Foot Ulcers [185 Words] [ Price : $8.95]
FDA approves Integra LifeSciences’ Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers.
01/07/2016
 
 
TXT Fast Track Status for Stealth’s Bendavia [86 Words] [ Price : $8.95]
FDA grants Stealth BioTherapeutics fast track status for MTP-131 (also known as Bendavia) for treating primary mitochondrial myopathy that is characterized by muscle weakness in patients with genetic mitochondrial diseases.
01/07/2016
 
 
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