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TXT Teva Approval for Zecuity Withdrawn [79 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of Teva’s NDA for Zecuity (sumatriptan iontophoretic transdermal system) after the company requested its withdrawal.
07/07/2020
 
 
TXT Clinical Hold on Cellectis CAR T Cell Therapy [152 Words] [ Price : $8.95]
FDA places a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died.
07/07/2020
 
 
TXT House Appropriators Approve $41 million Boost [420 Words] [ Price : $8.95]
A House appropriations subcommittee approves by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021.
07/07/2020
 
 
TXT REMS Web Site Updates Listed [2587 Words] [ Price : $8.95]
FDA publishes a list of the latest REMS updates for five drugs.
07/07/2020
 
 
TXT Latest FDA Warning Letters [344 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Greiner Bio-One, Luminex Corp. and Vega Life Sciences.
07/07/2020
 
 
TXT Info Collection on Radioactive Drug Research Committees [80 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for “Radioactive Drug Research Committees.”
07/07/2020
 
 
TXT QS, MDR Violations at Luminex Corp. [2810 Words] [ Price : $8.95]
FDA warns Luminex Corp. about QS and MDR violations in its production of multiplexing systems.
07/07/2020
 
 
TXT FDA Alert on BD Covid-19 Reagents [147 Words] [ Price : $8.95]
An FDA safety alert warns about an increased risk of a false positive result with Becton Dickinson’s BD SARS-CoV-2 Reagents for the BD Max System test.
07/06/2020
 
 
TXT Exceptions to Labeling for Stockpiled Products [110 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile.”
07/06/2020
 
 
TXT Novartis Settles ‘Sham Speaker Programs’ for $678 Million [2701 Words] [ Price : $8.95]
The Justice Department says Novartis will pay $678 million to settle a whistleblower suit alleging that it operated a sham speaker program to funnel money and gifts to doctors to encourage them to prescribe Novartis drugs.
07/06/2020
 
 
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