[ Price : $8.95]
CDRH director Dan Schultz tells RAPS the agency intends to establish a unique device identifier system for medical devices to redu...[ Price : $8.95]
Consulting editor John Scharmann follows up on responses to his article of measuring compliance, observing that the situation warr...[ Price : $8.95]
CBER director Jesse Goodman says current concerns over terrorism, including bioterrorism, are increasingly occupying the Centers r...[ Price : $8.95]
Asked to provide his best advice for industry in their dealings with the agency, CDER Office of New Drugs director says be honest ...[ Price : $8.95]
CDRH special assistant Casper Uldriks says FDA investigators are closely examining medical device Corrections and Removals reporti...[ Price : $8.95]
FDA issues a guidance for sponsors submitting applications for HIV fixed dose combination therapies.[ Price : $8.95]
FDA approves Mercks Januvia for treating Type 2 diabetes alone or with two other common diabetes drugs.[ Price : $8.95]
FDA says Qiagen GmbH does not have an approved PMA for ASRs it is marketing directly to clinical laboratories.