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According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff. Read More
A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More
The FDA’s 11-person Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed both the efficacy and safety of Lilly’s antiamyloid antibody donanemab, saying that people with Alzheimer’s disease and their clinicians should be the ones to decide whether the drug’s modest cognitive benefit outweighs its risk of serious adverse events. Read More
The FDA sent an untitled letter to Achieve Vitality, which markets a product claiming to offer regenerative therapy, for offering an injectable product derived from human umbilical cord for which the company lacks required regulatory approvals. Read More
The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency. Read More
Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according to inspections expert David Chesney. Read More
CDER, as part of its Emerging Drug Safety Technology Program (EDSTP) will hold meetings for drug makers and others to discuss their research, development, and use of AI and other emerging technologies in pharmacovigilance. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe, despite the serious adverse events related to the deaths of five people during the drug’s pivotal phase 3 trial. Read More