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FDA Renews Certara eCTD Legacy Licenses

[ Price : $8.95]

FDA renews Certaras legacy licenses for its GlobalSubmit drug and biologics review software for another year.

Atropine Sulfate Not Withdraw Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or ef...

Regulatory Review Period for MedEl EAS Hearing Device

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Med-El Electromedizinische ...

Info Collection Extension on Transplant Tissues

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Human Tissue Intended for Transplantation ...

Electronic Format Regulatory Submission Guidance

[ Price : $8.95]

FDA publishes the first in a series of guidances with standards for medical device submissions in electronic format.

FDA Slowness Helped e-Cig Epidemic: Rep. Pallone

[ Price : $8.95]

House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017...

FDA Gives Danicopan Breakthrough Designation

[ Price : $8.95]

FDA grants breakthrough therapy designation to Achillion Pharmaceuticals danicopan for treating paroxysmal nocturnal hemoglobinuri...

Abiomeds Newest Heart Pump Approved

[ Price : $8.95]

FDA approves Abiomeds newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) a...

FDA Breakthrough Status for Concussion Device

[ Price : $8.95]

FDA grants Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating co...

Florida Canadian Drug Importation Plan

[ Price : $8.95]

Florida submits a concept paper to HHS explaining how it wants to operate a Canadian prescription drug importation program.