The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes ...

In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products. While the guidance is not binding, it provides industry ...

Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination ...

ST. PAUL, Minn. & ST. LOUIS--(BUSINESS WIRE)--Kindeva Drug Delivery (“Kindeva”) and Meridian Medical Technologies (“Meridian”) announced today the completion of the transaction to combine the two ...

Dublin, Dec. 23, 2025 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course ...

Genus Medical Technologies, LLC v. FDA legal case leads to agency-wide review and reclassification of eye cups, eye droppers, and ophthalmic dispensers “While we were surprised by the FDA’s position ...

Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the ...

The last decade has witnessed an onslaught of home-based technology, from smartphones with their integrated cameras, apps, and wireless communications to voice-activated web appliances like Amazon’s ...

Abbott is a prominent key player in the global drug device combination products market. Abbott's Medical Devices segment delivers a combination of products, particularly in high-impact areas such as ...

The global drug device combination products market is expected to reach $115.1 billion by 2019, growing at a compound annual growth rate of 7.9 percent, according to a news release. In 2012, the ...