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Welcome to FDAweb Pay Per View Search our 72,047 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 Next >>   Humanitarian Use Devices Info Collection Comments [110 Words] [ Price : $8.95] Federal Register notice: FDA seeks comments on an information collection revision entitled “Medical Devices; Humanitarian Use Devices — 21 CFR Part 814.” 04/07/2022     Whole Slide Imaging in Tox Studies [2699 Words] [ Price : $8.95] FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies. 04/07/2022     Califf Plan to Improve Healthcare Outcomes, Equity [2721 Words] [ Price : $8.95] FDA commissioner Robert Califf lays out a six-step plan to better leverage health technology, data, and capabilities to improve healthcare outcomes and equity. 04/07/2022     ORA Shares MRA Experience During Pandemic [530 Words] [ Price : $8.95] FDA associate commissioner for regulatory affairs Judith McMeekin shares ORA’s experience during the pandemic about relying on inspection reports under its mutual recognition agreement with the European Union. 04/07/2022     Comments on Presser Assessment Guidance [2817 Words] [ Price : $8.95] Six drug companies comment on an FDA draft guidance on assessing drug presser effects. 04/06/2022     FDA Lists 6 OMB-approved Info Collections [133 Words] [ Price : $8.95] Federal Register notice: FDA announces that six information collections that have been approved by OMB. 04/06/2022     Ways to Expedite Gene Therapy Development: Marks [2701 Words] [ Price : $8.95] CBER director Peter Marks outlines ways in which FDA and other stakeholders could expedite the development of gene therapies. 04/06/2022     Hepatitis B Drug Development Guidance [2622 Words] [ Price : $8.95] FDA publishes a guidance to help sponsors develop drugs and biologics to treat chronic hepatitis B virus. 04/06/2022     ICH Addendum to M7(R2) Out [2614 Words] [ Price : $8.95] FDA publishes for comment a draft of revisions to the International Council for Harmonization M7 guideline on calculating compound-specific acceptable intakes. 04/06/2022     Comments on Human Immunogenicity Info Guidance [2662 Words] [ Price : $8.95] Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human prescription therapeutic protein and select drug products. 04/06/2022     << Prev  20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39  Next >>

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