Two decades in the making, a mutual recognition agreement between the FDA and EMA is now fully implemented. Slovakia was the last EU member state to get the FDA's seal of approval for its conduct of drug manufacturing inspections.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.
The Institute for Clinical and Economic Review (ICER) unveiled its preliminary list of potential assessment topics for next year. The list is based on the projected timing and likelihood of FDA approval, and whether an evidence review would suggest specific actions for payers, physicians, patients and policymakers to improve clinical practice.
The World Health Organization (WHO) Tuesday updated its list of essential medicines, with a focus on cancer and other global health challenges. WHO added 28 drugs for adults and 23 for children to the medicines list and specified new uses for 26 drugs already on the list.
The U.S. Court of Appeals for the Federal Circuit Friday unsealed its decision in the patent lawsuit between Enzo Life Sciences Inc. and a group of defendant-appellees led by Roche Molecular Systems Inc., affirming a lower court's decision to grant summary judgment against Enzo for lack of enablement of the disputed patent claims.
In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice requirements.
The FDA's Center for Drug Evaluation and Research (CDER) issued 62% more warning letters under the first part of the Trump administration than it did during the last few years of the Obama administration. But the number of warnings for medical devices, food and tobacco products fell sharply under President Donald Trump, according to an investigative report being published in the July 5 issue of Science.
Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.