A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

The U.S. Food and Drug Administration (FDA) announced it is changing its approach to direct-to-consumer (DTC) drug advertisements after a directive from a White House Memo instructing FDA and HHS to ...

Every January, pharmaceutical companies increase the prices of hundreds of drugs. This year there's a disconnect between the ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...

The templated letter sent across industry reiterates many of the same concerns highlighted in the press release and serves as notice of FDA’s enforcement approach to all drug application holders, ...

The U.S. health regulator on Tuesday asked drugmakers to remove label warnings about a potential risk of suicidal thoughts ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...