FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Human Genome Sciences and Novartis Scrap Zalbin

[ Price : $8.95]

Human Genome Sciences and its development partner, Novartis, decide not to further develop Zalbin (albinterferon alfa-2b) after re...

FDA May Go After Internet Pharmacy Domain Names

[ Price : $8.95]

A Domain Incite report says FDA may be preparing to take stronger action to shut down Internet domain names of pharmacies illegall...

FDA 'Orphan Status' for Prolor Growth Hormone

[ Price : $8.95]

FDA grants Prolor Biotech an orphan drug designation for hGH-CTP, a long-acting human growth hormone.

Aeterna Zentaris Granted 'Orphan' Status for Hormone Deficiency Test

[ Price : $8.95]

FDA grants Aeterna Zentaris an orphan drug designation for Solorel (macimorelin) and its use as an oral diagnostic test for adult ...

CDRH Considering Developing 42 Guidances in 2011

[ Price : $8.95]

CDRH publishes for comment a list of 42 guidances it is considering developing in 2011.

Consolidate CMC Guidances: BIO

[ Price : $8.95]

Industry commenters on an FDA draft guidance on reportable post-manufacturing changes say FDA should consolidate its CMC reporting...

Jazz Pharma Says FDA Received ANDA for Xyrem

[ Price : $8.95]

Jazz Pharmaceuticals says FDA has indicated that an ANDA has been submitted for a generic version of its narcolepsy drug Xyrem.

Info on Export Certificates Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on export of FDA-regulated products and export certifica...

Comments Sought on IVD Device Labels

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the reporting requirements for a collection of information on educational outreach ...

Comments Sought on Consumer Risk/Benefit Surveys

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the national consumer surveys that assess public understanding of the risks and ben...