FDA says it will publish early next year a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet...
FDA approves Sanofi-Aventis Admelog (insulin lispro injection), a Humalog follow-on and short-acting insulin indicated to improve control in blood sug...
CDERs Office of Testing and Research outlines research it is conducting to better understand 3D or additive manufacturings use in making drug products...
FDA approves an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease...
FDA Review posts the latest Federal Register notices for the week ending 12/8/2017
FDA Review posts product approval summaries for the week ending 12/8/2017.
Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled Fostering Digital Health Innovation: Developing the Software Precertifi...
Federal Register notice: FDA announces a 3/15/2018 public meeting entitled Oncology Center of Excellence: Listening Session.