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Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments...[ Price : $8.95]
Eisai files a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril ...[ Price : $8.95]
FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography dru...[ Price : $8.95]
CDER launches its new Accelerate Rare disease Cures program to speed and increase the development of effective and safe treatment ...[ Price : $8.95]
Mesa Biotech recalls its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive...[ Price : $8.95]
FDA warns inhousepharmacy.vu that it is illegally marketing domperidone drug products in the U.S.[ Price : $8.95]
FDA says the Skippack Medical Laboratory recall of rapid Covid-19 tests that were not cleared, approved, or authorized is Class 1 ...[ Price : $8.95]
A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HH...