The US Food and Drug Administration (FDA) has big plans to boost the quality of pharmaceutical products through the creation of its new Office of Pharmaceutical Quality (OPQ). But its success perhaps ...

The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes ...

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s wider attack on direct to ...

The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of frequently asked questions.

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer and other diseases, the U.S. patent office is making it harder for the ...

Organizational changes and layoffs that began in 2025 make me worry that the agency will struggle to fulfill its crucial mission ...

FDA chief Marty Makary resigns amid turmoil; food policy head Kyle Diamantas steps in as acting commissioner during leadership transition.