We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The CMS notice comes after U.S. Supreme Court decision that ruled the agency had underpaid for 340B medications from 2018 through most of 2022. Read More
EMA has issued revised guidance for its PRIority MEdicines (PRIME) scheme that provides early consultation and scientific advice between applicants and regulators for medicines under development and not currently authorized in the EU. Read More
Optimizing dietary management during drug trials is critical to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance. Read More
CMS has issued a proposed rule that aims to spend $9 billion to reimburse nearly 1,650 hospitals participating in the 340B drug discount program for underpayment of fees over the past five years. Read More
Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Read More
The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the “extraordinary regulatory flexibilities” that were put in place during the COVID-19 pandemic to ease potential medicine shortages. Read More
Use of real-world data (RWD) and real world evidence (RWE) continues to gain traction in countries around the world, as seen in a draft reflection paper endorsed by the International Council on Harmonisation and issued for comment by the European Medicines Authority (EMA). Read More
In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price negotiation provisions, but the changes don’t lessen the law’s overall power to require pharmaceutical companies to sell medications to the government at what they fear will reflect below-market rates. Read More
Feedback on the FDA’s draft guidance for incorporating clinical outcome assessments (COA) into endpoints has trickled in from a number of stakeholders, including BIO and the International Society for Cell & Gene Therapy, who feel the guidance would be well served with expansion and clarification in certain areas. Read More