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TXT BLOCKING Act Would Hurt Generic Drug Access: Attorneys [2866 Words] [ Price : $8.95]
Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry into the marketplace.
05/25/2022
 
 
TXT Revise Dietary Supplement Listing Bill: Researchers [2864 Words] [ Price : $8.95]
Harvard Medical School researchers call for major changes to dietary supplement listing proposed legislation.
05/25/2022
 
 
TXT Fast Track for Elevation’s Seribantumab [2589 Words] [ Price : $8.95]
FDA grants fast track designation for Elevation Oncology’s seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.
05/25/2022
 
 
TXT inHeart 3D Cardiac Ablation Planning Software Cleared [154 Words] [ Price : $8.95]
FDA clears an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use during cardiac ablation.
05/25/2022
 
 
TXT FDA OKs Tibsovo Expanded Use in Leukemia [118 Words] [ Price : $8.95]
FDA approves a Servier supplemental NDA for Tibsovo (ivosidenib tablets) in combination with azacitidine for treating newly diagnosed IDH1-mutated acute myeloid leukemia in adults 75 years or older, or those who have comorbidities that preclude use of intensive induction chemotherapy.
05/25/2022
 
 
TXT Q&A Guide on Importing Canadian Drugs [77 Words] [ Price : $8.95]
Federal Register notice: FDA releases a final guidance entitled “Importation of Prescription Drugs Final Rule Questions and Answers.”
05/25/2022
 
 
TXT Phathom NDA for Erosive Esophagitis NDA Accepted [116 Words] [ Price : $8.95]
FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief of heartburn.
05/25/2022
 
 
TXT Drug Importation Small Entity Q&A [2624 Words] [ Price : $8.95]
FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug importation.
05/25/2022
 
 
TXT Comments Extended on Drug Distributor Rule [51 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug distributors that published 2/4.
05/24/2022
 
 
TXT FDA Revokes EUA for Covid Test [63 Words] [ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at the Broad Institute of MIT and Harvard for the CRSP SARS–CoV–2 Real-time Reverse Transcriptase — PCR Diagnostic Assay because testing under the EUA has ceased.
05/24/2022
 
 
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