FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Asked to End Ranbaxy ANDA Exclusivity

[ Price : $8.95]

An OFW Law client tells FDA it supports a petition asking the agency to rule that Ranbaxy has lost its 180-day exclusivity for sev...

Advisors Asked to Assess Farydak Risk/Benefit

[ Price : $8.95]

FDA asks members of its Oncologic Drugs Advisory Committee to weigh the benefits of Novartis Farydak in patients with relapsed mul...

Hospira Class 1 Recall of Infusion Pump Power Supply

[ Price : $8.95]

Hospira begins a Class 1 recall of its GemStar Power Supply, 3VDC, due to performance issues.

CMS Exempts Medical Education from Sunshine Act Reporting

[ Price : $8.95]

The Centers for Medicare & Medicaid Services revises its reporting requirements under the Physician Payments Sunshine Act to exclu...

CNS Drugs Take Longer to Develop, Have Lower Success

[ Price : $8.95]

A Tufts Center for the Study of Drug Development analysis finds that central nervous system drugs take longer to develop and appro...

QS Violations Found in BioMerieux U.S. Facility

[ Price : $8.95]

FDAs Kansas City District Office warns BioMerieux about Quality System violations at its Hazelwood, MO, facility.

FDA Clears Covidiens HawkOne Atherectomy System

[ Price : $8.95]

FDA clears a Covidien 510(k) for the HawkOne directional atherectomy system.

Inspection Finds QS Problems at Xanacare Technologies

[ Price : $8.95]

The FDA Denver District Office warns Xanacare about Quality System and other violations in its manufacturing of the SimulCare II t...

Drug Companies Need to Change Mobile App Approach: Attorney

[ Price : $8.95]

Attorney Vinay Bhupathy says drug companies need to take a new approach if they are to successfully promote their mobile apps.

FDA Sends Info on Antibacterial Drugs/Antimicrobial Testing to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...