FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Workshop on Clinical Outcome Assessments

[ Price : $8.95]

Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for reg...

FDA Starts TMD/TMJ Web Pages

[ Price : $8.95]

FDA launches temporomandibular disorders Web pages.

Info Collection on Combo Product Jurisdiction

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Compo...

CGMP Deviations Found in Mylan Unit 8

[ Price : $8.95]

FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.

Cadila Healthcare CGMP Violations

[ Price : $8.95]

FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.

BD PMA Supplement to Expand HPV Assay

[ Price : $8.95]

Becton Dickinson files a PMA supplement for an expanded version of its BD Onclarity HPV Assay.

FDA OKs Hologics 3DQuorum Imaging Technology

[ Price : $8.95]

FDA approves a Hologic PMA for its 3DQuorum Imaging Technology for use with the companys Clarity HD high resolution imaging techno...

Panel Urges Risk-based Sterility Assurance for Devices

[ Price : $8.95]

Worried about device shortages that could occur from recent closures of facilities that use ethylene oxide to sterilize medical de...

3 IMDRF Clinical Documents Published

[ Price : $8.95]

The International Medical Device Regulators Forum issues three final guidances relating to clinical evaluation, clinical evidence,...

FDA Reports New Vascepa Safety Concerns

[ Price : $8.95]

FDA medical reviewers ask the Endocrinologic and Metabolic Diseases Advisory Committee to discuss efficacy and safety information ...