FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments Sought on Clinical Trial Regs

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on clinical investigation regulations for the safety and effectiveness of unapproved d...

Bio-Rad Labs Pays $14 Mil. Over Illegal Sales to Russia

[ Price : $8.95]

Bio-Rad Laboratories agrees to pay a $14.35 million penalty to resolve allegations that it violated the Foreign Corrupt Practices ...

Pediatric Subcommittee to Discuss 3 Cancer Therapies

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 12/11 to discuss pediatric development plans for three pro...

Support Voiced for Duchenne Muscular Dystrophy Guidance

[ Price : $8.95]

Comments offer suggestions to strengthen a proposed FDA draft guidance on drug development to treat Duchenne muscular dystrophy.

FDA Grants Orphan Drug to Merrimack for Pancreatic Cancer Drug

[ Price : $8.95]

FDA grants orphan drug designation to Merrimack Pharmaceuticalss for its drug candidate MM-141 for treating pancreatic cancer.

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...

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.