Federal Register notice: FDA announces a 9/20 public meeting entitled Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspe...
FDA clears a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System.
FDA publishes a draft osteoarthritis medical product development guidance.
FDA contracts with the National Academies to advance development of opioid prescribing evidence-based guidelines.
The 3rd Circuit Appeals Court upholds a lower court ruling dismissing a whistleblower suit brought by the federal government and several states agains...
FDA issues Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding in women with uteri...
Federal Register notice: FDA announces a 10/19 public meeting entitled Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Contro...
Federal Register notice: FDA determines that Ditropan XL (oxybutynin chloride) extended release tablets 15mg were not withdrawn from sale for safety o...