Recently introduced bicameral, bipartisan legislation could make it easier for competitors to enter the generic and biosimilar market by putting controls on patent thickets created by pharmaceutical companies. Source: Drug…
Delving into the development of AI in healthcare, Google researchers have penned an analysis of how AI has grown from a mere concept in the 1950s to be a dominant…
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by…
The Jan. 5 FDA announcement of its authorization of Florida’s program to import prescription drugs from Canada isn’t what it seems. Source: Drug Industry Daily
This edition of Quick Notes includes coverage of a cloth vest/halter that continuously monitors blood pressure, a Mayo Clinic deal on a newly cleared breast tumor 3D modeling device, and…
The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Source: Drug Industry Daily
After evaluating reports of suicidal thoughts or action in patients taking diabetes and weight loss drugs containing glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as Ozempic/Wegovy, Byetta, Trulicity and…
Over the past week, the FDA issued a final guidance viral safety evaluation of biotechnology product derived from human or animal cells and draft guidance on sterility information in 510(k)…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid out the final roadmap for 2024 to create a comprehensive set of regulations for medical devices and technology, bringing…
To address the ongoing U.S. shortages of Bicillin L-A, a drug used to treat syphilis, the FDA has temporarily approved French manufacturer Laboratoires Delbert to import 3.6 million units of…