Latest news with #drugreview
Washington Post
19-06-2025
- Health
- Washington Post
How we plan to cut FDA drug approval time by months
Marty Makary is the commissioner of the Food and Drug Administration. For more than a century, the U.S. Food and Drug Administration has been a global leader in advancing medical cures, but in recent years, its regulatory framework has become an obstacle to innovation. Cumbersome requirements, poor communication and regulatory creep have made the United States less competitive in the global race for new drugs and treatments. Meanwhile, countries such as Australia and China, with more streamlined regulations, have become go-to destinations for clinical trials and early drug testing. The shift poses a risk not just to U.S. competitiveness but also to national security. To address it, the FDA must modernize. That's why I have just announced a pilot program that can slash the FDA's drug review time from 10 to 12 months to just one to two months. The program will make use of the idle time during clinical trials — time needed to see how the drug in question performs. Instead of submitting all the data at the end of a trial, qualifying manufacturers will be able to submit most elements of the application — including manufacturing details and drug labeling — while the trial is underway. The FDA will be able to review the early data and resolve any issues with the manufacturer at that time. Once the trial concludes, final data will be submitted. Then there will be about one month of FDA review, followed by a focused, one-day meeting with FDA scientists to reach a decision. This split-submission approach is entirely feasible — as shown by its success during Operation Warp Speed at the start of the covid-19 pandemic. This novel program tackles a common pain point voiced during my national listening tour: inaccessibility of FDA reviewers for clarifying questions. Pharmaceutical CEOs repeatedly told me a simple 15-minute call with their reviewer could save months of wasted work. Our new program adopts a real-time communication model, eliminating guesswork. No more mind-reading; drug developers will get straight answers when they're needed. As a surgical oncologist, I've experienced firsthand the benefits of team-based decision-making as a participant in 'tumor board' meetings where specialists collaborate to make critical decisions. A similar team approach can be applied at the FDA to evaluate the safety and efficacy of new drugs. In my first 12 weeks leading the FDA, we've made significant strides toward modernizing the agency. One example is the launch of Elsa, a tool powered by artificial intelligence that helps FDA reviewers sift through thousands of pages of data in minutes, instead of days. This tool is already being used by thousands of FDA staff daily, enabling them to focus more on what matters most: scientific expertise. Elsa doesn't replace human judgment but accelerates the review process, making the FDA more efficient and responsive. We're also speeding up approvals by phasing out outdated animal testing, replacing it with cutting-edge tools such as computational modeling and organ-on-a-chip toxicity testing, where a miniaturized, three-dimensional tissue mimics human function. These techniques are faster, cheaper and better at predicting human toxicity. Notably, about 90 percent of drugs that pass animal studies fail in humans. The FDA has even required animal studies on drugs already approved in Europe. We need both gold-standard science and common sense. Newer methods can be more predictive and humane. For drug developers, time is money. A previous valuable priority review program for rare pediatric diseases shortened FDA review time from 10 to 12 months to six. The market value of the six-month review was approximately $100 million to the pharmaceutical companies, showing that faster approval processes can be highly valuable. A one-month review process could be significantly more valuable and could incentivize companies to act on national priorities. These could include boosting domestic manufacturing for national security, addressing unmet public health needs or developing products for pandemic preparedness. The new national priority review program is designed to align speed, science and strategy. It rewards companies working on innovative solutions to real challenges faced by the American public, without sacrificing safety or the FDA's rigorous standards. By modernizing the FDA, we can ensure that the future of medicine is written in the United States. .
Bloomberg
17-06-2025
- Business
- Bloomberg
FDA Announces New Vouchers to Cut Drug Reviews to Two Months
The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one to two months for companies it says are backing national interests. The Commissioner's National Priority Voucher program will slash review times from the current average of 10 to 12 months, the agency said in a statement on Tuesday. In the first year of the program, the FDA plans to give the vouchers to a limited number of companies 'aligned with U.S. national priorities,' it said.
Reuters
17-06-2025
- Business
- Reuters
US FDA to shorten review time for drug developers under new voucher program
June 17 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it is launching a program under which its commissioner can issue vouchers to companies to shorten their review time for a drug application to 1-2 months from the typical timeline of about 10-12 months. The new Commissioner's National Priority Voucher (CNPV) program convenes experts from the regulator's offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices, the agency said. The FDA plans to give a limited number of vouchers to companies aligned with U.S. national priorities in the first year of the program. The new program aims to accelerate the drug review process while maintaining the FDA's rigorous standards for safety, efficacy and quality, the regulator said.
Reuters
29-05-2025
- Business
- Reuters
China investigating former head of food and drug watchdog
BEIJING, May 29 (Reuters) - Bi Jingquan, former head of the now-defunct China Food and Drug Administration (CFDA), is being investigated for suspected corruption, China's anti-graft watchdog said on Thursday. Bi, a member of the standing committee of China's top political advisory body and a deputy director of its committee for economic affairs, is being investigated for suspected serious violations of law and discipline, the watchdog said, without giving details. Reuters was not able to reach Bi for comment. Bi, 69, holds a degree in economics from the prestigious Peking University and has served in senior positions in the National Development and Reform Commission, China's state planner, and State Council, China's cabinet. He was appointed chief of the CFDA in early 2015, a few months before the government launched a major revamp of China's drug review procedure. During his tenure at CFDA, Bi spearheaded efforts to simplify and expedite the review process for new drugs, and introduced steps to improve the quality of generic drugs. In 2018, Bi resigned from the CFDA amid fallout from a major vaccine scandal.
Yahoo
11-05-2025
- Business
- Yahoo
The FDA Will Use AI to Accelerate Approving Drugs
The Food and Drug Administration just announced that it will immediately start using AI across all of its centers, after completing a new generative AI pilot for scientific reviewers. Supposedly, the AI tool will speed up the FDA's drug review process by reducing the time its scientists have to spend doing tedious, repetitive tasks — though, given AI's track record of constantly hallucinating, these claims warrant plenty of scrutiny. "This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days," said Jinzhong Liu, a deputy director in the FDA's Center for Drug Evaluation and Research (CDER), in a statement. FDA commissioner Martin Makary has directed that all FDA centers should achieve full AI integration by June 30, a questionably aggressive timeline. "By that date, all centers will be operating on a common, secure generative AI system integrated with FDA's internal data platforms," the agency said in its announcement. The announcement comes just a day after Wired reported that the FDA and OpenAI were holding talks to discuss the agency's use of AI. Notably, the FDA's new statement makes no mention of OpenAI or its potential involvement. Behind the scenes, however, Wired sources say that a team from the ChatGPT maker met with the FDA and two associates from Elon Musk's so-called Department of Government Efficiency multiple times in recent weeks, to discuss a project called "cderGPT." The name is almost certainly a reference to the FDA's abovementioned CDER, which regulates drugs sold in the US. This may have been a long time coming. Wired notes that the FDA sponsored a fellowship in 2023 to develop large language models for internal use. And according to Robert Califf, who served as FDA commissioner between 2016 and 2017, the agency review teams have already been experimenting with AI for several years. "It will be interesting to hear the details of which parts of the review were 'AI assisted' and what that means," Califf told Wired. "There has always been a quest to shorten review times and a broad consensus that AI could help." The agency was considering using AI in other aspects of its operations, too. "Final reviews for approval are only one part of a much larger opportunity," Califf added. Makary, who was appointed commissioner by president Donald Trump, has frequently expressed his enthusiasm for the technology. "Why does it take over ten years for a new drug to come to market?" he tweeted on Wednesday. "Why are we not modernized with AI and other things?" The FDA news parallels a broader trend of AI adoption in federal agencies during the Trump administration. In March, OpenAI announced a version of its chatbot called ChatGPT Gov designed to be secure enough to process sensitive government information. Musk has pushed to fast-track the development of another AI chatbot for the US General Services Administration, while using the technology to try to rewrite the Social Security computer system. Yet, the risks of using the technology in a medical context are concerning, to say the least. Speaking to Wired, an ex-FDA staffer who has tested ChatGPT as a clinical tool pointed out the chatbot's proclivity for making up convincing-sounding lies — a problem that won't go away anytime soon. "Who knows how robust the platform will be for these reviewers' tasks," the former FDA employee told the magazine. More on medical AI: Nonverbal Neuralink Patient Is Using Brain Implant and Grok to Generate Replies
