Federal Register notice: FDA posts a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the F...
Federal Register notice: FDA seeks public comments on a proposed information collection entitled Text Analysis of Proprietary Drug Name Interpretation...
Datascope/Getinge/Maquet recalls its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs due to a battery failure risk.
An Illinois federal judge sentences a former Aegerion Pharmaceuticals sales rep to 54 months in prison for using the identities of physicians to carry...
Johnson & Johnson takes a $800 million hit to settle substantially all outstanding cases against its Risperdal drug product over personal injury claim...
FDA says that beginning 11/15 new requirements under the FDA-approved Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program require all pat...
Federal Register notice: FDA withdraws approval of 18 NDAs from multiple applicants because the drug products are no longer marketed.