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Welcome to FDAweb Pay Per View Search our 65,496 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   CDRH Listing on Upcoming Guidance Documents [118 Words] [ Price : $8.95] Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019     Info Collection on 510(k) 3rd-party Reviews [82 Words] [ Price : $8.95] Federal Register notice: FDA submits to OMB an information collection extension for “510(k) Third-Party Review Program.” 10/11/2019     Innoveix Pharma Recalls Drugs Over Sterility Concerns [79 Words] [ Price : $8.95] Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns. 10/11/2019     Info Collection Extension for CVM eSubmissions [85 Words] [ Price : $8.95] Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvm’s electronic submission system. 10/11/2019     FDA Hits Cipla in India with 38-page Form-483 [129 Words] [ Price : $8.95] FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India. 10/11/2019     Lilly’s Reyvow Approved for Migraines [222 Words] [ Price : $8.95] FDA approves Eli Lilly’s Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults. 10/11/2019     FDA Clears Think Surgical Robotic Knee Replacement [97 Words] [ Price : $8.95] FDA clears a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty. 10/11/2019     JAMA Article Raises Doubt on Replicating Trials [429 Words] [ Price : $8.95] A new study in JAMA suggests there is limited feasibility for the idea of replicating clinical trials using real-world evidence. 10/11/2019     FDA Clears Turn Therapeutics Wound Dressing [54 Words] [ Price : $8.95] FDA clears a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing. 10/11/2019     7 Observations on Aurobindo FDA-483 [2785 Words] [ Price : $8.95] FDA releases an FDA-483 with seven observations from an inspection at an Aurobindo finished drug manufacturing facility. 10/10/2019       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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