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Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations

As we previously reported, lawmakers in the House of Representatives are moving closer this month to cracking down on pharmaceutical companies that abuse the agency’s accelerated approval pathway, but the pending legislation is friendlier to the pharmaceutical industry than previous versions. The House Energy and Commerce Committee announced in early May that the user fee […]

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FDA Sends Warning Letter To Miami University Contract Testing Laboratory For Poor QC And Faked Data

A Miami University contract testing lab received an FDA warning letter last month for not ensuring that drugs were tested appropriately and preventing data from being altered or deleted. According to the FDA warning letter sent on April 20, the agency stated that the contract testing laboratory’s Department of Biochemistry and Chemistry didn’t follow cGMPs […]

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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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