Tag Archives: FDA

In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products, revealing trends in the reliance on single pivotal trials and the racial/ethnic diversity of trial participants. This analysis by AgencyIQ offers a midpoint overview of drug approval processes and characteristics, including drugs’ indications, mechanisms, and […]

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This text provides a brief insight into a report by AgencyIQ analyzing the drug approvals made by the FDA’s Center for Drug Evaluation and Research (CDER) in the first half of 2024. During this period, CDER approved 21 novel drug products. The analysis focuses on the number of these approvals that were based on a […]

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Over the years, there has been a growing awareness of the links between thyroid hormones and mood disorders, particularly depression. Autobahn Therapeutics, a pioneer in this field, is harnessing this relationship by developing a novel treatment aimed at enhancing the efficacy of depression medications when traditional antidepressants fall short. Autobahn’s breakthrough centers around the targeted […]

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Jeff Shuren, the longstanding director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), announced his decision to retire after a remarkable 15-year tenure. His departure is scheduled for later this year, with the transition of leadership beginning on July 28. Michelle Tarver, currently the deputy director for transformation at […]

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I’m sorry for any confusion, but the text you’ve provided seems to be an introductory snippet or a description of an article rather than the full article itself. It mentions that the FDA issued a final rule in April 2024 to update regulations regarding Laboratory Developed Tests (LDTs) and notes potential impacts from Supreme Court […]

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The Food and Drug Administration (FDA) has increased its scrutiny of plastic syringes manufactured in China, issuing additional warnings to two companies, Jiangsu Shenli Medical Production and Jiangsu Caina Medical, for failing to meet quality standards. Jiangsu Shenli, which had previously received a warning in March, was sent another warning following a later inspection of […]

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Jeffrey Shuren, a key figure in the regulation of medical devices at the U.S. Food and Drug Administration (FDA), recently announced his decision to step down from his position, ending a tenure of 28 years at the agency. Shuren, who began his career at the FDA in 1998 within the Commissioner’s Office, later ascended to […]

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Over the past decade, significant strides have been made in the understanding and treatment of food allergies. This evolution was significantly highlighted through Dr. Kari Nadeau’s pioneering clinical trials at Stanford University with 85 food allergy patients, published by the New York Times 11 years ago. Dr. Nadeau’s work has paved the way for groundbreaking […]

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The Food and Drug Administration (FDA) uses the “breakthrough” designation to fast-track the development and review of drugs and devices aimed at treating severe conditions, with potential improvements over existing therapies. Despite similar development processes involving significant investment and clinical trials, breakthrough devices face a notably less predictable and longer path to reimbursement compared to […]

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Sun Life, an organization focused on employee and government benefits, has recently partnered with Hinge Health to enhance its musculoskeletal (MSK) care offerings through digital solutions. This collaboration will give Sun Life members specialized access to a range of Hinge Health’s services, including health coaching, orthopedic surgery consultations, physical therapy, and technology like surgery decision […]

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