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Welcome to FDAweb Pay Per View Search our 70,821 - 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 >>   CBER Warns Firm on Cellular Product [96 Words] [ Price : $8.95] CBER sends NYC Regenerative Medicine an untitled letter over its Web site and Facebook page that markets its cellular product derived from human umbilical cord for treating kidney disease and other conditions. 11/15/2021     FDA Terminates Kalidindi Debarment [68 Words] [ Price : $8.95] Federal Register notice: FDA issues an order granting special termination of the debarment involving Sanyasi Raju Kalidindi. 11/15/2021     Qinlock Regulatory Review Period Determined [32 Words] [ Price : $8.95] Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Deciphera Pharmaceuticals’ Qinlock (ripretinib), indicated for treating adult patients with advanced gastrointestinal stromal tumors. 11/15/2021     China Valsartan API Firm Resolves GMP Issues [303 Words] [ Price : $8.95] FDA issues a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer that is the reported maker of the active ingredient in recalled valsartan-containing products over the past several years. 11/15/2021     HHS Reverses FDA Policy on Lab-Developed Tests [581 Words] [ Price : $8.95] HHS withdraws a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests. 11/15/2021     Revised Guide on Covid Test Transport Media [112 Words] [ Price : $8.95] FDA posts a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency. 11/15/2021     Baxter Recalls PrisMax Hemodialysis Device [140 Words] [ Price : $8.95] Baxter Healthcare recalls its PrisMax System Version 2, a high permeability hemodialysis device, due to a software design error. 11/12/2021     FDA Hits Philips with 29-page 483 Over Recalled Device [461 Words] [ Price : $8.95] An FDA inspection of Philips Respironics results in a 29-page Form FDA-483 based on a Class 1 recall follow-up involving its continuous and non-continuous ventilators. 11/12/2021     Biden Taps Ex-FDA Head Califf as Next Commissioner [610 Words] [ Price : $8.95] The Biden Administration chooses former FDA head Robert Califf as its FDA commissioner nominee. 11/12/2021     Apellis NDA Planned for Geographic Atrophy [206 Words] [ Price : $8.95] Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blindness causing condition — geographic atrophy. 11/12/2021     << 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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