[ Price : $8.95]
CDRH issues a standard operating procedure for reviewing IDE application-specific issues.[ Price : $8.95]
CBER says New York Fertility Institute has achieved compliance with regulations and can resume full manufacturing of HCT/Ps.[ Price : $8.95]
FDA warns Hospira Australia about CGMP violations at its Victoria drug manufacturing plant.[ Price : $8.95]
Researchers say they have developed a drug capsule that uses needles to deliver a biologic directly to the stomach lining and keep...[ Price : $8.95]
FDA says it will publish a final guidance for medical device manufacturers on promoting cybersecurity in their products.[ Price : $8.95]
Zogenix files a supplemental NDA for a reformulated version of its controversial pain drug Zohydro ER (hydrocodone bitartrate) ext...[ Price : $8.95]
FDA releases its five-year GDUFA information technology plan with objectives for five main goals.[ Price : $8.95]
Federal Register Notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for FY 2015.