The release of added context on the benefit-risk profile of CAR-T therapies underscores how safety is moving from the periphery into the category’s forefront.
FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.
FDA’s plan to ban hair relaxer chemical called too little, too late
In April the Food and Drug Administration is tentatively scheduled to unveil a proposal to consider banning the chemical in hair-straightening products.
FDA commissioner Robert Califf: Adcomm reforms coming, praises AI potential
In a fireside chat, FDA commissioner Robert Califf provided an update on the agency’s 2024 budget, AI regulation in healthcare and the larger drug shortage problem.
Why the FDA wants to add boxed warnings to all six CAR-T drugs
The class-wide warning follows an investigation the FDA launched last fall around the risk of T-cell malignancy associated with autologous CAR-T therapies.
Inside the FDA’s plans for the largest reorganization in its history
In response to concerns about its organizational structure following the infant formula crisis, the FDA announced a sweeping revamp plan in how it manages inspections.
How the FDA’s move on drug importation could shape medical marketing
The FDA’s approval of Florida’s plan to import drugs is official. Healthcare marketers will have to develop communication around the law’s process and impact to patients and stakeholders.
FDA OKs Florida’s plan to import drugs from Canada