Officials of the various regulatory agencies after the signing ceremonyThe Food and Drugs Authority (FDA) has signed a Memorandum OF Understanding (MOU) with eight African National Medicine ...
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.
The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...
MDR Certification Strengthens Resyca's Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development an ...
The import of pre-owned and refurbished, or second-hand, medical devices into India will not be allowed by the Central Drugs Standard Control Organisation (CDSCO) until a regulation is established for ...
Instructions for filling out the medical device establishment licence application. Information includes a calculation chart for the required fees and related guidance documents.
Meanwhile, other countries continue to allow Red Dye No. 3 in certain applications, meaning imported foods must comply with U.S. regulations upon entry . The FDA's decision to ban Red Dye No. 3 ...