Forbes says a proposed CMS rule requiring drug companies to include the list price of most prescription drugs in their TV ads is likely to confuse con...
The Justice Department Office of Legal Counsel says FDA lacks jurisdiction to regulate articles intended for use in carrying out capital punishment by...
AdvaMed voices approval for the current 510(k) program and for some efforts to improve it.
The Pew Charitable Trusts lays out reasons why Congress should revise the system to update over-the-counter product monographs.
FDAs Oncologic Drugs Advisory Committee votes not to recommend approval of a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with re...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
FDA approves a W. L. Gore PMA for the Gore Tag Conformable Thoracic Stent Graft with Active Control System, an endovascular aortic repair device.
FDA approves a Genentech supplemental NDA for Venclexta (venetoclax) in combination with the companys Gazyva (obinutuzumab) for treating people with p...