FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Info Collection Extension for Dear Doctor Letters

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.

AbbVies Humira Follow-on Approved for Arthritis

[ Price : $8.95]

FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbust...

Heart Valves Get Expanded Indication

[ Price : $8.95]

FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis w...

FDA Draft Guide on X-ray Equipment Regs

[ Price : $8.95]

FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment...

Proposed Rule on Drug Labeling Changes Withdrawn

[ Price : $8.95]

Federal Register proposed rule withdrawal: FDA announces the withdrawal of a proposed rule on Supplemental Applications Proposing ...

Guide on Manufacturing Site Change Supplements

[ Price : $8.95]

FDA posts a guidance entitled Manufacturing Site Change Supplements: Content and Submission.

EhmetDx Positioning Software Cleared

[ Price : $8.95]

FDA clears an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment ...

Approval Withdrawn for 9 ANDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants.

Drug GMP Data Integrity Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Data Integrity and Compliance With Drug CGMP: Questions and...

Celltrion BLA for Herceptin Biosimilar

[ Price : $8.95]

FDA approves a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentechs Herceptin (trastuzumab) for patients wit...