Stakeholders comment on an FDA 2018 public meeting on drug shortage causes and solutions.
FDA posts a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.
Natures Rx recalls its Silver Bullet 10x product because it was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra ...
FDA issues a guidance to help medically necessary drug product manufacturers develop contingency plans for when manufacturing facilities are hit by hi...
A Healthcare and Public Health Sector Coordinating Council working group releases a Joint Security Plan with recommendations to address cybersecurity ...
FDA commissioner Scott Gottlieb says FDA is looking at a process to help patients navigate the expanded access protocol and put the agency in direct c...
FDA grants Merck a breakthrough therapy designation for its V114 investigational 15-valent pneumococcal conjugate vaccine, indicated for preventing in...
FDA issues a new drug marketing status notification guidance, an initial step in enhancements to the Orange Book.