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Welcome to FDAweb Pay Per View Search our 72,320 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   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     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     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     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     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     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     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     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     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on Power Morcellator Containment Devices [80 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” 06/21/2022     << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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