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TXT Meeting on User Fee FDA-Sponsor Communications [110 Words] [ Price : $8.95]
Federal Register notice: FDA announces an 8/11 public meeting entitled “Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI.”
07/21/2020
 
 
TXT FDA Panel to Review Mesoblast BLA [119 Words] [ Price : $8.95]
Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemcel-L for acute graft-versus-host disease in pediatric patients.
07/21/2020
 
 
TXT Pieris Pharma Study of Cancer Drug on Hold [344 Words] [ Price : $8.95]
FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an additional in-use and compatibility study requested by the agency.
07/21/2020
 
 
TXT FDA Withdraws Approval of 10 ANDAs [62 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed.
07/21/2020
 
 
TXT Draft Guide on Appealing Mammography Actions [102 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders.”
07/21/2020
 
 
TXT Cannabis Research Quality Guidance [2673 Words] [ Price : $8.95]
FDA issues a draft guidance on quality considerations for clinical research related to developing drugs containing cannabis or cannabis-related compounds.
07/21/2020
 
 
TXT New COA Grant Funding Opportunity [2695 Words] [ Price : $8.95]
FDA offers a second funding opportunity to develop core sets of clinical outcome assessments for four areas.
07/21/2020
 
 
TXT FDA Not Cutting Vaccine Standards: Companies [2856 Words] [ Price : $8.95]
Drug company executives try to reassure a House committee that FDA will not lower its standards to approve a Covid-19 vaccine.
07/21/2020
 
 
TXT FDA Approves Boston Scientific Watchman FLX [2619 Words] [ Price : $8.95]
FDA approves Boston Scientific’s Watchman FLX left atrial appendage closure device.
07/21/2020
 
 
TXT HCT/P Manipulation and Homologous Use Guidance [2661 Words] [ Price : $8.95]
FDA issues a guidance with its current thinking on the regulatory criteria for human cells, tissue, and cellular and tissue-based product minimal manipulation and homologous use.
07/21/2020
 
 
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