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The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. Read More
The FDA has adopted an updated guidance from the International Council on Harmonisation (ICH) that provides clarification on how to factor in new and increasingly used data sources, such as social media or patient support programs, when reporting individual case safety reports postapproval. Read More
Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Read More
Manufacturers of cyber devices must have a plan to keep those devices secure for the product’s entire lifecycle, and sponsors of nonprescription drugs can include some minor labeling changes on an annual report, according to two new draft guidances issued by the FDA. Read More
Drugs for cognitively and functionally normal people who have the pathophysiologic changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD. Read More
Manufacturing and distributing adulterated drugs for nearly a decade — some of which originated in a foreign country without FDA authorization — has brought $3.5 million in penalties to a Pennsylvania generic pharmaceutical company. Read More
Real-time communication between sponsors and regulators is a top priority for Nicole Verdun, the recently installed Super Office director for the Office of Therapeutic Products (OTP). Read More