[ Price : $8.95]
FDA grants fast track designation to Xbiotech for its monoclonal antibody therapy for treating all forms of Staphylococcus aureus ...[ Price : $8.95]
FDA clears an EarLens Corp. de novo petition for the EarLens Contact Hearing Device, a new hearing aid that uses a laser diode and...[ Price : $8.95]
The DC federal court says that Eisai is not entitled to an extension of its marketing exclusivity for two drugs whose market entry...[ Price : $8.95]
Allergan says FDA should not think it can be talking with ANDA first applicants for generic Restasis because no generic drug compa...[ Price : $8.95]
FDA publishes a draft International Conference on Harmonization guidance on enhancing the format and structure of benefit-risk inf...[ Price : $8.95]
BIO says an FDA draft guidance on formal meetings between the agency and sponsors of PDUFA products will give additional clarity.[ Price : $8.95]
Companies welcome an FDA guidance on dissolution testing and raise additional concerns.[ Price : $8.95]
Presentations by CDER, CBER and CDRH advertising and promotion officials discuss current issues and violations observed at the age...