Emery Pharma calls on FDA to take multiple steps to control ranitidine products that can develop NDMA when exposed to high temperatures such as during...
Stakeholders raise questions on an FDA draft guidance on submitting IND safety reports in electronic format to FAERS.
Teva agrees to pay $54 million to settle a whistleblower suit alleging that it used sham speaker and consulting programs to reward doctors for prescri...
FDA releases its latest batch of Warning Letters that includes one medical product company Apollo Health and Beauty Care.
FDA grants Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with relapsed or refracto...
FDA warns Canadas Apollo Health and Beauty Care about CGMP violations in its work as a contract manufacturer of OTC drugs.
FDA clears a PhotoniCare 510(k) for its TOMi Scope for non-invasive imaging of the middle ear.
FDA clears an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel for use on the BioCode MDx-3000 System.