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Advisors Say Cervarix is Safe, Effective Against HPV

[ Price : $8.95]

FDA advisors find that GSKs Cervarix is effective and safe in preventing HPV cervical cancers.

Penumbra Recalls Catheters

[ Price : $8.95]

FDA says that Penumbra recalled nine catheters 5/29 due to a manufacturing error in a Class 1 recall.

FDA Approves Salix Metozolv ODT

[ Price : $8.95]

FDA approves Salix orally disintegrating tablet formulation of metoclopramide for two indications.

Extremes Author Has Lessons for FDA, Industry

[ Price : $8.95]

A new book, Going to Extremes, helps explain our polarized society and provides timely lessons in sound decision-making for both F...

On LASIK We Screwed Up Says Ex-CDRH Review Chief

[ Price : $8.95]

In yet another setback for CDRH, the Centers former chief of LASIK device reviews tells us the agency screwed up in failing to set...

FDA Releases Modified Device Consensus Standards

[ Price : $8.95]

Federal Register Notice: FDA releases the Modifications to the List of Recognized Standards for use in premarket reviews for devic...

FDA, PDA Plan Conference on Product Quality

[ Price : $8.95]

Federal Register Notice: FDA and the Parenteral Drug Association will co-sponsor a conference 9/14-16 entitled Securing the Future...

Draft Guidance on HPV Differentiation, Detection

[ Price : $8.95]

FDA publishes a draft guidance with recommendations for studies to establish analytical and clinical performance of devices for de...

CytRx Planning Revised Arimoclomol Trial Protocol

[ Price : $8.95]

CytRx says it plans to submit to FDA a revised arimclomol Phase 2b trial protocol before the end of this year.

Goozner Launches Analytical Health Tech Newsletter

[ Price : $8.95]

Former Center for Science in the Public Interest Integrity in Science project director Merrill Goozner launches a new weekly healt...