Vitang Technology, a Tustin, Calif.-based manufacturer of 3D printed dental alignment devices, failed to seek the FDA’s clearance when it changed the software used with its UniSmile Clear Aligner, the…
This month, our review of recent clinical trial results features Rinvoq’s sustained remission in almost half of Crohn’s disease patients, Novo Nordisk’s semaglutide showing significant patient weight loss, and improved…
CDER formal dispute resolution (FDR) procedures on how to appeal a final order for OTC monograph drugs are outlined in a draft guidance the FDA released on Thursday. Source: Drug…
Heavy reliance on foreign manufacturing for essential medicines is at the root of FDA concerns over supply chain and drug shortages, according to a report from the FDA Office of…
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. Source: Drug…
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…
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…
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. Source: Drug Industry Daily
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…
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…