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The FDA issued a warning yesterday about the risk of false results from noninvasive prenatal screening (NIPS) tests, also known as cell-free DNA tests or noninvasive prenatal tests. Read More
Frisco, Tex.-based InspectIR Systems has gained the FDA’s first Emergency Use Authorization (EUA) for an affordable breath-based diagnostic test for COVID-19 infection, and other companies are working on similar analyzers for the pandemic disease. Read More
Gauthier Biomedical, a spinal and orthopedic surgical instrument manufacturer in Grafton, Wisc., has received a five-observation Form 483 from the FDA following an inspection in which the agency’s investigator observed several repeat deficiencies from a previous inspection in 2016. Read More
A California state appeals court has ruled that Johnson & Johnson (J&J) must pay $302 million in civil penalties in one of the long-running cases against the company and its Ethicon subsidiary over its pelvic mesh products, a reduction from almost $344 million awarded by a lower court.
The California Superior Court ruled Jan. 30, 2020, that J&J engaged in false and deceptive marketing of its pelvic mesh products for women and ordered the company to make the higher payout. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has released a Manual of Policies and Procedures (MAPP) document that explains how the agency will classify complex new drug products and drug-device combination products assigned to CDER. Read More
The Department of Health and Human Services (HHS) has declared that the COVID-19 public health emergency (PHE) will continue for at least three more months, which means devicemakers will need to need to continue to adhere to the many guidances the FDA released that contain pandemic-specific directives. Read More