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An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher l...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for tr...[ Price : $8.95]
FDA clears a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a r...[ Price : $8.95]
FDA updates its (XXX DELETE EXTRA SPACE XXX)Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers,...[ Price : $8.95]
A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integra...[ Price : $8.95]
FDA approves a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....