FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Gottlieb Calls for Congress Help with AI Device Regulation

[ Price : $8.95]

Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical a...

Indivior Pulls Plug on Schizophrenia Drug Marketing

[ Price : $8.95]

Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperido...

Bausch+Lomb Recalls I-Pack Injection Kit

[ Price : $8.95]

Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal...

FDA Withdraws Takeda NDA for Exkivity

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmator...

AskBio Gets Fast Track for Parkinsons Gene Therapy

[ Price : $8.95]

FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating mod...

2 Updated Guides on Dental Resin and Curing Lights

[ Price : $8.95]

Federal Register notice: FDA releases two draft guidances entitled Dental Composite Resin Devices Premarket Notification (510(k))...

Oticon Sentio Hearing Device Cleared

[ Price : $8.95]

FDA clears an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System.

Rinvoq sNDA for Giant Cell Arteritis Filed

[ Price : $8.95]

AbbVie submits a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis.

Hamilton Medical Recalls Ventilators

[ Price : $8.95]

Hamilton Medical recalls its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilatio...

Baxter Recalls Life2000 Ventilators

[ Price : $8.95]

FDA says Baxter is recalling its Life2000 ventilators that were distributed in the U.S. between 8/2023 and 4/2024 due to potential...