FiercePharma3d
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
FDA clears sepsis test that significantly reduces life-or-death diagnosis time
Sepsis, a life-threatening organ dysfunction, is responsible for an estimated 1 in 5 deaths globally and 1 in 3 deaths that ...
The National Law Review4d
Proposed FDA Rule May Require Stricter Testing for Talc in Cosmetic Products
Recent federal developments may soon require cosmetic companies to adopt stringent precautions to ensure that talc-containing ...
Healio1d
Direct-to-consumer genetic testing for cancer predisposition can have ‘pitfalls’
Genomic cancer predisposition tests should be done with professional counseling, and the FDA should implement safeguards for ...
Don’t use this nasal spray: FDA says it may cause ‘adverse’ effects
STATEN ISLAND, N.Y. — The U.S. Food and Drug Administration (FDA) has announced a recall of 89,312 bottles of a popular nasal ...
Targeted Oncology9d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...