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TXT 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
 
 
TXT 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FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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Six drug companies comment on an FDA draft guidance on assessing drug presser effects.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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human prescription therapeutic protein and select drug products.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
 
 
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