Drug Industry Daily

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. Source: Drug Industry Daily

The FTC’s lawsuit to block the merger of Amgen and Horizon violates the companies’ right to due process as, with the case relegated to an administrative law judge (ALJ) and not a jury, the commission will be “playing the roles of ‘investigator, prosecutor, and judge,’” the companies said in their June 29 counterclaim filing. Source:…

The Case for Quality (CfQ) — an FDA initiative in which the agency works closely with the public-private partnership the Medical Device Innovation Consortium (MDIC) — has key programs coming to fruition in its mission to get the industry to focus on continuous improvement in their quality operations. Source: Drug Industry Daily

Feedback on the FDA’s draft guidance for incorporating clinical outcome assessments (COA) into endpoints has trickled in from a number of stakeholders, including BIO and the International Society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. Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

While most comments on the FDA’s draft guidance on providing predetermined change plans for devices that include use of AI or machine learning (ML) offer improvements of one sort or another, one commenter doesn’t believe such change plans are even needed. Source: Drug Industry Daily

Deeply embedded supply chain challenges, such as “just in time” manufacturing methodology and sole sourcing to maximize profit, are key drivers of low inventories and offshoring, said Mark Abdoo, associate commissioner of FDA’s Office for Global Policy and Strategy (OGPS) in a recent speech. Source: Drug Industry Daily

Certain recalled extended dwell catheters from Teleflex, and its subsidiary Arrow International, have a risk of separating while still in the blood vessel, resulting in the FDA deeming the recall Class I because of the risk of serious injury or death. Source: Drug Industry Daily

Drugmakers should make use of risk-based thinking to help prevent “catastrophic failures,” said quality expert Amanda McPharland in a June 14 WCG FDAnews webinar. Source: Drug Industry Daily

Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B. Source: Drug Industry Daily