PMIC supplier GMT pessimistic about market prospects
Global Mixed-mode Technology (GMT), a supplier of power management ICs (PMIC), has maintained its generally cautious view for 2025, as…
Despite global disruptions, TSMC and Nvidia bolster Taiwan’s semiconductor supply chain
In late 2024, Nvidia’s Blackwell AI GPUs encountered supply chain disruptions, including design setbacks, production bottlenecks at TSMC, and cooling…
TSMC approves US$17.1B capital appropriation to boost advanced technology, packaging, and fab upgrades
Taiwan Semiconductor Manufacturing Company (TSMC) has released its financial and strategic plans for the coming year as its board approved…
Study of Sex Differences in the Clinical Evaluation of Medical Products
This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific…
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
AKT Trading Inc. Recalls Seasoned Bamboo Shoots Because of Possible Health Risk
AKT Trading Inc of Torrance, California is recalling 120 packages of Menma Ajitsuke Prepared Bamboo Shoot Product, because it has…
Questions and Answers on Current Good Manufacturing Practices for Drugs
As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be…
Search for Regulatory References | Drugs
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Drug Quality Sampling and Testing Programs
FDA CDER’s quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult…