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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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FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application

Teva and French biotechnology company MedinCell have intended to compete in the competitive schizophrenia drug market, but their NDA was recently rejected by FDA. FDA sent both companies a full response letter this month. It rejected their request for drug approval for a subcutaneous version of the drug risperidone. Teva told the media it is […]

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Indian API Plant Receives FDA 483

The Indian API company Lupin has been criticized by FDA before. After it was cited for inadequate manufacturing operations and other cGMP violations last summer, the genetics drug company still has not cleaned up its operations. Now Lupin’s API plant in Tarapour, India has been hit by an FDA 483 after an FDA inspection from […]

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Questions Remain After FDA Offers New Designation To Medical Device Manufacturers

In 2017, FDA launched a new regulatory program to speed up the development of medical devices. It’s estimated the program has helped a minimum of 45 medical devices come to market. It is believed more than 650 medical devices have what is known as ‘breakthrough designation’, which means FDA thinks the device could be more […]

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FDA Appears To Be Tightening Regulations For Drug Approvals

In a recent endometriosis application for Myfembree by Myovant and Pfizer, FDA included language that is being seen more often, according to pharmaceutical experts. In the FDA notice, the agency noted deficiencies that prevent discussion of labeling or post-marketing requirements and commitments. This might look like gobbledygook, but some industry analysts are starting to see […]

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2 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation

Two US drug manufacturers were hit with an FDA warning letter recently for cGMP violations connected to inadequate investigations, sloppy testing of incoming ingredients, as well as improper ethanol screening. Other FDA issues were related to improper validation of drug manufacturing processes, and both companies were hit with repeat violations. The FDA warning letters were […]

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