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CDRH announces new organizational changes to help it meet commitments under the Medical Device User Fee Amendments reauthorization...[ Price : $8.95]
Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.[ Price : $8.95]
FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmator...[ Price : $8.95]
FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating mod...[ Price : $8.95]
Federal Register notice: FDA releases two draft guidances entitled Dental Composite Resin Devices Premarket Notification (510(k))...[ Price : $8.95]
FDA clears an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System.[ Price : $8.95]
AbbVie submits a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis.