FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient manufacturing facility....
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical conve...
FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patient...
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.
FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys production of injectable we...
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standa...
