FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves New Myeloid Treatment

[ Price : $8.95]

FDA approves Pfizers Daurismo to be used with low-dose cytarabine to treat some new cases of acute myeloid leukemia.

More Device Inspections Yields Better Compliance: CDRH

[ Price : $8.95]

A CDRH report says there is improved medical device manufacturer compliance as a result of increased inspection oversight using a ...

Mylan Says Morgantown Plant Remediation Underway

[ Price : $8.95]

Mylan says it is addressing an FDA Warning Letter about its Morgantown, WV, drug manufacturing plant in the context of a comprehen...

FDA Faulted for Late Product Identifier Guidance

[ Price : $8.95]

Some stakeholders fault FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act just mont...

Info Collection on Drug Labeling Content/Format

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension entitled Requirements on Content and Format of Lab...

Daiichi Sankyo Quizartinib NDA for Acute Myeloid Leukemia

[ Price : $8.95]

FDA accepts for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD...

Mylan Recalls Contaminated Valsartan Products

[ Price : $8.95]

FDA says Mylan has recalled 15 lots of valsartan-containing drugs that tested positive for NDEA above acceptable levels.

Orphan Status for OBI Pharma Pancreatic Cancer Drug

[ Price : $8.95]

FDA grants OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer.

NEWSROOM CLOSED FOR THANKSGIVING

[ Price : $8.95]

The FDA Webview newsroom is closed in observance of the U.S. Thanksgiving Day holiday -- reopens Monday, November 26.

FDA Approves Elite Pharma Generic Norco

[ Price : $8.95]

FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).