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The FDA has updated how the Office of Pharmaceutical Quality (OPQ) will select manufacturing sites for routine surveillance inspection, using information about the compliance history of sites “to promote parity in inspectional coverage and the effective and efficient use of FDA resources to address the most significant public health risks.” Read More
CDRH’s new development initiative — Total Product Life Cycle Advisory Program (TAP) — taps into an FDA goal: to ensure U.S. patients are first to benefit from innovative medical devices that, while developed quickly, are of high quality, safe and proven effective, and that include input from patients, providers and payers early in the process. Read More
Nearly 20 percent of AI and machine learning (ML) devices in a study had discrepancies between FDA-cleared indications for use and information included in marketing materials, according to a report published Wednesday in JAMA Open Network.. Read More
The Association for Accessible Medicines (AAM) says that the “looming” Nov. 27 Drug Supply Chain Security Act deadline requiring interoperable exchange, verification and tracing for all drug products, could cause a spike in drug shortages. Read More
The FTC’s amicus brief in a product-bundling case has “broad implications for antitrust enforcement in the healthcare sector and beyond,” the FTC says, regarding its analysis of Medtronic’s motion to dismiss in a case that also involves exclusive-dealing. Read More
Amneal Pharmaceuticals’ recent complete response letter (CRL) for its investigational Parkinson’s extended-release drug IPX203 didn’t identify any issues with efficacy or manufacturing — just the safety of one of the two ingredients in the NDA. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and webinars on the FDA’s sterilization pilot and design control. 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
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. Read More
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. 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
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More