FDA warns Family Pharmacy of Statesville, NC, about multiple drug compounding violations.
FDA issues a final guidance on Certificates of Confidentiality, which describes the agencys implementation of revised provisions under the 21st Centur...
Alkermes says it is working with FDA on issues raised in an agency complete response letter for the firms NDA for ALKS 3831 to treat schizophrenia and...
CDER deputy Center director for clinical science Bob Temple opines on meetings with industry on product development issues that may be suffering from ...
FDA releases its latest batch of Warning Letters that include Family Pharmacy and Quten Research Institute.
Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.
CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar User Fee reauthoriz...
CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment pilot project that ...