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Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
The International Council for Harmonisation’s (ICH) governing group announced earlier this month it will begin work on new guidelines in three areas: patient preference, nonclinical safety evaluation for oligonucleotide-based therapies and bioequivalence for modified-release products. Read More
After five years of development, a program to help devicemakers improve and accelerate their corrective and preventive action (CAPA) programs is ready to implement but its creators worry the industry will not be ready to adopt the model. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA’s sterilization pilot and design control. Read More
To better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients, the FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays. Read More
Bristol Myers Squibb (BMS) filed suit against HHS and CMS over the Inflation Reduction Act (IRA) claiming that the drug price negotiation program violates the Constitution by “forcing pharmaceutical companies to turn over their most successful and innovative products at a huge discount.” Read More
The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. 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
An artificial intelligence platform can discern epileptic seizure patterns on electroencephalogram as well as an expert epileptologist, with nearly 100 percent accuracy, a finding that could extend expert diagnoses to clinics without access to specialists in epilepsy, according to a report in JAMA Neurology. Read More
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered. Read More
Coherus BioSciences has resolved a key piece of its dispute with AbbVie over plans to market Yusimry (adalimumab-aqvh), a biosimilar for AbbVie’s blockbuster immunotherapy Humira, enabling it to begin selling the product July 1 at an 85 percent discount from AbbVie’s price. Read More
Failure to establish corrective and preventive action (CAPA) plans tops the list of devicemakers’ FDA inspection observations year after year, but the situation is more nuanced than you might expect, according to one regulatory expert. Read More