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TXT Medtronic IDE Approved for Laser Use in Epilepsy Treatment [1230 Words] [ Price : $8.95]
FDA approves a Medtronic IDE for a pivotal study called SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy).
06/20/2016
 
 
TXT Guidance on Veterinary Parenteral Dosage Forms [92 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.
06/17/2016
 
 
TXT FDA Releases Product-Specific BE Recommendations [48 Words] [ Price : $8.95]
Federal Register Notice: FDA makes available draft and revised draft product-specific bioequivalence recommendations.
06/17/2016
 
 
TXT Guidance on Chewable Tablet Quality [80 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Quality Attribute Considerations for Chewable Tablets.
06/17/2016
 
 
TXT Ex-Drug Co. Head Found Not Guilty in Kickback Scheme [1470 Words] [ Price : $8.95]
In another setback for the Obama Administration’s get-tough crackdown on FDA-regulated company executives in fraud cases, a federal jury acquits former Warner Chilcott president W. Carl Reichel of conspiring to pay kickbacks to physicians.
06/17/2016
 
 
TXT Ariad Pharma NDA for Non-small Cell Lung Cancer Drug [1220 Words] [ Price : $8.95]
Ariad Pharmaceuticals files an NDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, seeking approval for use in patients with ALK+ non-small cell lung cancer who are resistant to crizotinib.
06/17/2016
 
 
TXT FDA Clears REBIScan Pediatric Eye Scanner [163 Words] [ Price : $8.95]
FDA clears a REBIScan 510(k) for the Pediatric Vision Scanner, a handheld device designed to help physicians screen for amblyopia (lazy eye) and strabismus (misaligned eyes) in young children, as early as preschool age.
06/17/2016
 
 
TXT FDA Accepts Emergent BioSolutions sBLA for BioThrax [138 Words] [ Price : $8.95]
FDA accepts for review an Emergent BioSolutions supplemental BLA seeking approval to make BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (building 55).
06/17/2016
 
 
TXT Guidance on Age, Race, Ethnicity in Device Trials [296 Words] [ Price : $8.95]
FDA releases a draft guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” that provides recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups.
06/17/2016
 
 
TXT Panel to Review First-In-Human Use of CRISPR/Cas9 Gene Editing [171 Words] [ Price : $8.95]
NIH’s Recombinant DNA Advisory committee plans a 6/21-22 meeting to review a protocol involving the first-in-human use of gene editing via CRISPR/Cas9 technology.
06/17/2016
 
 
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