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FDA says it would determine on a case-by-case basis whether an ANDA or 505(b)(2) application citing Tevas ProAir as the reference ...[ Price : $8.95]
Abrams Royal Pharmacy recalls all unexpired lots of its sterile compounded products due to a lack of sterility assurance.[ Price : $8.95]
FDA clears a Royal Philips 510(k) for the Spectral Breast Density Measurement Application for its MicroDose SI full-field digital ...[ Price : $8.95]
FDA approves an Xlumena de novo petition for the AXIOS Stent and Delivery System for treating pseudocysts that form in the pancrea...[ Price : $8.95]
Attorneys writing the Drug and Device Law blog urge drug and medical device companies to argue federal preemption of off-label saf...[ Price : $8.95]
Sandoz initiates a Phase 3 study of its biosimilar version of AbbVies Humira.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on testing commun...[ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 3/28/14: FDA/American Academy of Ophthalmology (AAO) Workshop on Developing N...