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TXT Merarini Files NDA for Breast Cancer Therapy [168 Words] [ Price : $8.95]
The Menarini Group submits an NDA for elacestrant and its use in patients with ER+/HER2 advanced or metastatic breast cancer.
06/22/2022
 
 
TXT Updated CBER Guidance Agenda [53 Words] [ Price : $8.95]
CBER updates its guidance agenda for 2022 containing 18 guidances it plans to develop.
06/22/2022
 
 
TXT Krystal Biotech BLA for Topical Gene Therapy [205 Words] [ Price : $8.95]
Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating patients with dystrophic epidermolysis bullosa.
06/22/2022
 
 
TXT Florida Man Arrested in HIV Drug Distribution Scheme [189 Words] [ Price : $8.95]
The U.S. government arrests Lazaro Hernandez of Miami, FL, for allegedly distributing over $230 million in adulterated HIV drugs.
06/21/2022
 
 
TXT Converted OTC Products are Not ‘Listed Drugs’: FDA [279 Words] [ Price : $8.95]
Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day exclusivity incentive for the first generic applicant.
06/21/2022
 
 
TXT Mexican Firm Refuses FDA Inspection [218 Words] [ Price : $8.95]
FDA warns Mexico’s Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspection.
06/21/2022
 
 
TXT Appeals Court Upholds WV Law on Misleading Lawyer Ads [406 Words] [ Price : $8.95]
Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff attorneys can advertise for clients in drug and medical device cases.
06/21/2022
 
 
TXT CBER Pilot Program for 510(k) eSubmissions [74 Words] [ Price : $8.95]
Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Template and Resource (eSTAR) pilot program.
06/21/2022
 
 
TXT Guide on Power Morcellator Containment Devices [80 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.”
06/21/2022
 
 
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