Regulatory Oversight and Compliance

June 21, 2023

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

June 16, 2023

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

June 08, 2023

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

June 08, 2023

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

June 05, 2023

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

June 05, 2023

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

June 02, 2023

What implications will EMA’s recent regulatory reform have on pharma?

June 02, 2023

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

June 02, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.

June 02, 2023

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.