On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...

Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

SAN ANTONIO, Tx - Cancer patients need a lot of drugs—immunotherapies, chemotherapies, and anti-infectives. But new research at ObesityWeek® on Nov. 3, 2024, shows clinicians may not have all the ...

The Obesity Action Coalition and other organizations are urging the FDA to address critical gaps in drug testing, emphasizing the need for specific testing in individuals with obesity to ensure safety ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...