Federal Register notice: FDA posts its annual report on the status of drug/biologic postmarketing requirements and postmarketing commitments.
FDA clears a Genea Biomedx 510(k) for its benchtop incubator Geri.
The Washington Legal Foundation urges FDA to replace all older guidances with formal regulations that undergo a notice-and-comment rulemaking process.
Federal Register notice: FDA extends the comment period on a 10/3 draft guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Pro...
FDA commissioner Scott Gottlieb says that across multiple science fields, we stand at an inflection point in medicine where new technology is creatin...
CNN says Avanir has paid some doctors facing disciplinary measures or criminal charges to promote its Nudexta.
Federal actuaries say the annual increase in spending on prescription drugs nationally was lower in 2016 than in the previous two years.
FDA commissioner Scott Gottlieb announces three new guidances to expand the agencys digital health efforts under the 21st Century Cures Act.