New tonight... Business owners say they're still learning how to adapt to a new T-H- C law. Some say the process to get products approved under the new guidelines has been a headache. Others say it's ...

This is part two of a two-part article offering proposals to improve the FDA’s draft guidance to implement a new approval ...

With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products, by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a ...

Digital therapeutics (DTx) provide innovative treatment options. In this study, we identified and compared approved DTx in China, the US, Germany, and Belgium. In total, 507 DTx applications were ...

Cell and tissue products approved in Japan can be classified into two groups (Table 1 and Supplementary Table 1). The first is products that compensate for organ function. All five products in this ...

How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Amneal Pharmaceuticals has announced the FDA approval of its prednisolone acetate ophthalmic suspension, a 1% sterile topical anti-inflammatory treatment intended for steroid-responsive ocular ...