Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.