Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws
A drug producer at one of the top hospitals in Boston received an FDA warning letter in April after the agency found its manufacturing practices for positron emission tomography drugs were not up to cGMP requirements. FDA sent the letter to Brigham and Women’s Hospital on April 11. The letter was written to Sunil Eappen, […]
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Generic Drug Manufacturer Slapped With FDA 483
A generic pharmaceutical manufacturer in India has been hit with a 483 after an FDA inspection of their oral manufacturing facility, Aurobindo Pharma announced in a statement this month. However, the company has not released many details. The drug plant is located in Jadcherla, India, near Hyderabad. The FDA audit started last week and finished […]
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US House Conducting User Fee Markup
The House has been working this month on reauthorizing the FDA user fee program. Also, there are reports that FDA is looking into a new program to make it easier for pharmaceutical companies to develop drugs for rare diseases where there has been an unmet medical need. Regarding the user fee markup, the House Energy […]
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Will FDA Update How It Approves Drugs After Alzheimer’s Mess?
Almost a year after FDA approved a controversial medicine to help Alzheimer’s disease, legislators are trying to amend the FDA drug approval process. The outcome of those efforts could have a significant impact on pharmaceutical companies in future years. The House Committee on Energy and Commerce is charged with oversight of US drug safety and […]
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FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill
The subcommittee on health in the House’s energy and commerce committee made an agreement across the aisle this week to not just stay behind user fee reauthorization that give the FDA most of its annual budget. They also supported various add-on bills that would improve FDA’s accelerated approval steps for new drugs. Regarding accelerated product […]
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FDA Turns Down China-Produced Cancer Drug
After FDA rejected an immunotherapy drug produced by Eli Lilly and Innovent Biologics, FDA has done the same thing with another cancer drug made in China. It was submitted to the agency with pivotal trial data only from China, and FDA deemed that it wasn’t good enough. Yesterday, Hutchmed told the media that FDA rejected […]
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FDA Rejects Axsome Migraine Medication, But Problems Are Addressable
FDA rejected Axsome Therapeutic’s migration medication last week, which was expected after the firm reported there were problems with CMC (chemistry, manufacturing, and controls) that were unresolved, according to FDA. the rejection of Axsome’s AXS-07 through a complete FDA response letter was announced by the company yesterday during its Q1 earnings report. But the company […]
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FDA Sends PI Warning Letter For Not Checking Trial Participants’ Eligibility
FDA sent a warning letter this month to a Georgia child neurologist because he enrolled clinical trial subjects into a study and an extension without ensuring they met clinical study criteria. The FDA warning letter didn’t have the details of the study that was involved. But the warning letter was sent to Daniel Tarquinio, who […]
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FDA Warning Clinical Trial Companies For Not Reporting Trial Results
FDA has restarted the policy of warning companies of $10,000 fines if they don’t report clinical trial results. In this case, they are warning clinical trial biotech company Ocugen. Most of us know Ocugen for attempting to bring a new COVID-19 vaccine to the US from India. The trial that is being questioned by FDA […]
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GAO Says FDAers Experienced Political Interference In Scientific Decisions During Trump Era
FDA and CDC employees during the Trump administration told the GAO recently that they didn’t report political interference in their regulatory work because they were afraid of retaliation. This came out in a Government Accountability Office report this week. The FOIA office at FDA released the report and also offered a glimpse of some behind […]
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