FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.
Baxter recalls (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the components handset ...
Federal Register notice: FDA determines that Pfizers Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to safety or effectivenes...
Two industry associations give line-by-line comments and edits on an International Council for Harmonization draft guidance on the planning, design, a...
The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favor of its suit challe...
FDA warns Chula Vista, CA-based SoloVital it is marketing a misbranded and unapproved hyaluronic acid drug product as a dietary supplement.
The Department of Justice says Californian Paul Lamberty pleaded guilty in a Massachusetts federal court to conspiracy to defraud the United States an...
Vanda Pharmaceuticals sues FDA, seeking an advisory committee meeting to assess the companys pending NDA for tradipitant and its use in treating sympt...
