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FDA publishes a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.[ Price : $8.95]
FDA posts a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.[ Price : $8.95]
Federal Register notice: FDA determines that Sandozs Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not...[ Price : $8.95]
Aldeyra Therapeutics says it is addressing substantive late review-cycle concerns raised by FDA on the companys NDA for reproxalap...[ Price : $8.95]
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,...