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The FDA Oncology Center of Excellence has announced Project Asha, an initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access in India. Read More
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Read More
Fake Botox has sent nine people to the hospital and caused harmful reactions in 10 others, prompting an FDA investigation and a warning about counterfeit forms of the neurotoxin from the CDC. Read More
The Pharmacy Care Management Association (PCMA), a national association representing pharmacy benefit managers, opposes state laws requiring PBMs to act in the best interests of health plans they serve, saying that contractual agreements are sufficient to ensure this fiduciary duty, according to a new report by the Government Accountability Office (GAO). Read More
Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products, among other lapses. Read More
Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay increases for both this year and next, according to the agency’s chief financial officer (CFO). Read More
A new CDER sub-center is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design. 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