Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Ti...
Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparativ...
Philips discusses proposed terms of a consent decree with FDA involving the companys troubled Respironics unit and its ventilators, continuous positiv...
Medical device maker Biotronik pays $13 million to resolve allegations that it violated the False Claims Act by causing false claims to be submitted t...
Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Answers.
Federal Register notice: FDA issues an order debarring Kenneth Zipperer for five years from importing or offering for import any drug based on his con...
Federal Register proposed rule: FDA proposes to amend its regulations to move to a new format for National Drug Codes.
Federal Register notice: FDA makes available a final guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and...