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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BIO says an FDA draft guidance on formal meetings between the agency and sponsors of PDUFA products will give additional clarity.[ Price : $8.95]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...[ Price : $8.95]
Justice Department Consumer Protection Branch assistant director Jill Furman says individual accountability for corporate wrongdoi...[ Price : $8.95]
Public Citizens Michael Carome says the New England Journal of Medicine breached its own ethics by publishing a commentary that gr...[ Price : $8.95]
FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with ...