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The drug alongside androgen deprivation therapy provided a median of 40.4 months of metastasis-free survival compared to placebo and ADT’s 18.4 months, a Phase 3 trial showed. Read More
The advertisement failed to mention contraindications for the product, including acute pelvic inflammatory disease or current behavior suggesting a high risk of pelvic inflammatory disease. Read More
The devicemaker also received manufacturing materials from a supplier that was not found on its approved supplier list, an issue the agency said was a recurring observation. Read More
Heparin, an intravenous anticoagulant, is an essential product in hospitals and is the only anticoagulant used in the U.S. for kidney dialysis and open heart surgeries, the committee said. Read More
The firm’s initial response to the mismatched data was insufficient, the agency said, calling the company out for failing to commit to a “comprehensive retrospective evaluation” of data integrity in its manufacturing operations. Read More
The agency said that manufacturers seeking certification for new products or maintaining existing certification may be affected by notified bodies that do not intend to transition to the new MDR, such as Lloyd’s Register and QS Zurich AG. Read More
Some Type II DMF submissions may receive a waiver for noncommercial applications, such as ones from an academic institution, government or non-profit research group. Read More
Drug companies that don’t adhere to the price requirements would be hit with a fine on all profits made from selling a drug above the HHS-defined “fair price” in the form of a 100 percent tax. Read More