FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Puma Delays Expected Filing of NDA for Neratinib

[ Price : $8.95]

Puma Biotechnology says it expects to file an NDA for neratinib for extended adjuvant treatment of HER2-positive early-stage breas...

FDA Pregnancy and Lactation Labeling Rule

[ Price : $8.95]

FDA issues a final rule and draft guidance on drug and biological product labeling for pregnancy and lactation information.

Hamburg on Female Representation in Clinical Trials

[ Price : $8.95]

FDA commissioner Margaret Hamburg discusses the improving representation of women in clinical trials.

FDA OKs PulmoFlow Drug/Device Combo for Cystic Fibrosis

[ Price : $8.95]

FDA approves a PulmoFlow NDA for Kitabis Pak a co-packaging of tobramycin inhalation solution with a Pari LC Plus Nebulizer for t...

Indian Drug Companies Fudge Test Results: News Service

[ Price : $8.95]

Bloomberg News reports that FDA documents show that many Indian drug manufacturers routinely delete test results showing potential...

Siemens Healthcare Class 1 Recall of Antibiotic Tests

[ Price : $8.95]

Siemens Healthcare Diagnostics begins a Class 1 recall of its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type...

Will Drop in CDRH Inspections Continue?

[ Price : $8.95]

Aptiv Solutions says the 2013 drop in medical device facility inspections by CDRH is not likely to continue into future years.

ContraFect Submits Response to Clinical Hold on CF-301

[ Price : $8.95]

ContraFect Corp. submits a response to FDA that it says addresses all of the issues identified in an IND clinical hold letter on C...

Dont Force Pharma to Consult FDA on Trials: LaMattina

[ Price : $8.95]

Former Pfizer executive John LaMattina says drug companies would be wise to consult with FDA on clinical trial protocols, but shou...

FDA OKs Amgen First to Treat Rare Leukemia

[ Price : $8.95]

FDA approves Amgens Blincyto, which uses the bodys T-cells to treat patients with relapsed or refractory Philadelphia chromosome-n...