Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Novo Nordisk, which has stumbled through a bit of a manufacturing hangover at a former Catalent production site it ...

The Food and Drug Administration has released additional information on several foodborne illness outbreaks in Executive ...

Sun Pharmaceutical Industries Ltd announced that its Baska manufacturing facility has been classified as Official Action ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...

Some staff members say they are frustrated with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The official in charge of federal food and drug safety ...

Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this ...

His departure comes at a time of many concerns within the agency, including staff frustrations with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The ...