Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial...

One purpose of the individual mandate is to eliminate the market for self-insured healthcare transactions. It is well-established in this Court's precedent that the elimination of an interstate commercial market is a constitutionally legitimate end for Congress to pursue under the Commerce...

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving...

Prevalent diabetes at the time of heart failure (HF) diagnosis is associated with a higher risk of death, but the incidence and prognostic importance of new-onset diabetes in patients with established HF remains unknown. Patients with a first hospitalization for HF in the period 2003–2014 were...