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TXT FDA Approves Gileads Vosevi for Hepatitis C [2724 Words] [ Price : $8.95]
FDA approves Gilead’s hepatitis C drug Vosevi for adults without cirrhosis or with mild cirrhosis.
TXT Latest FDA Warning Letters [401 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Center for Reproductive Health, ChemRite CoPac, National Biological Corp. and Tubilux Pharma.
TXT Otonomy File sNDA for Otiprior in Swimmer’s Ear [136 Words] [ Price : $8.95]
FDA accepts an Otonomy supplemental NDA seeking approval of Otiprior (ciprofloxacin otic suspension) as a treatment for acute otitis externa (swimmer’s ear).
TXT Comments Sought on Biologic Adverse Event Reporting [119 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.”
TXT Comments Sought on Combination Product Guidance [137 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on a new information collection related to a “Draft Guidance for Industry — How To Prepare a Pre-Request for Designation” that outlines requests for feedback from the Office of Combination Products on whether a medical product will be regulated as a drug, a device, a biologic, or a combination product.
TXT DoJ Views on ‘Responsible Executive’ Prosecutions [3004 Words] [ Price : $8.95]
Attorney Michael Blume says Justice Department briefs in the DeCoster Quality Egg case appeals give valuable insights into how it will prosecute corporate executives it considers to be responsible for company violations.
TXT Gottlieb Moves to Overcome Hundreds of Scientific Vacancies [470 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb orders a “comprehensive” review of the agency’s hiring practices and procedures in order to speed up processes to bring new scientific talent to FDA.
TXT Complete Response Letter on Amgen Bone Drug [227 Words] [ Price : $8.95]
FDA issues Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.
TXT Repros’ Proellex Remains on Hold Over Liver Safety Data [235 Words] [ Price : $8.95]
FDA tells Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating uterine fibroids, will remain on partial clinical hold based upon its review of existing liver function safety data.
TXT CDER Revises Policy on Posting Approval Info [76 Words] [ Price : $8.95]
FDA revises an internal policy on “Communicating Drug Approval Information” that demands quicker online posting, from three days to two days, for the approved labeling for recently approved drugs.
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