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FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.[ Price : $8.95]
FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biologica...[ Price : $8.95]
A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to ...[ Price : $8.95]
The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.[ Price : $8.95]
FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an addit...[ Price : $8.95]
FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrep...[ Price : $8.95]
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.