[ Price : $8.95]
A just-released FDA Form-483 says Irvine, CA-based device maker Masimo failed to adequately investigate complaints about potential...[ Price : $8.95]
FDA updates its Medication Guides Web page to add nine updated and three new guides.[ Price : $8.95]
FDA rejects a citizen petition from Neurelis that asked FDA to refrain from approving any intranasal product for treating epilepsy...[ Price : $8.95]
CDER says generic drug post-market evaluations and complex products equivalence top the list of fiscal year 2015 regulatory scienc...[ Price : $8.95]
U.S. federal judge Paul Gardephe denies a Novartis motion to dismiss anti-kickback claims in a whistleblower suit originally filed...[ Price : $8.95]
FDA seeks a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manuf...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on electronic record and signatures to the Office of Man...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).