FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs
A drug manufacturing facility that is owned by the Netherlands-based API company Fagron Group is being criticized by FDA after a worker was found destroying a cleaning log. One of the company’s plants in Minnesota got an FDA warning letter in June after a cGMP inspection in 2021 that showed several cross-contamination problems. FDA stated […]
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FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
FDA cited Spanish drug ingredient maker Bioberica with an FDA 483 in May. The drug facility, which is located in Spain, was inspected by FDA inspectors in January and February 2022. During the audit, FDA found several cGMP issues involving improper cleaning procedures and microbiological contamination. The company was cited with five 483 observations, including […]
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FDA Approves New Cancer Drugs Faster Than EMA
The FDA is faster to approve new cancer drugs compared to the EMA or European Medicines Agency, according to a study released in JAMA Network Open last week. Investigators at Imperial College London did a clinical study involving 90 cancer drugs that were approved by the FDA and EMA between 2010 and 2019. They looked […]
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FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic
Every year, FDA keeps track of how effectively it inspects drug manufacturing facilities and how often it issues FDA inspection follow-up letters to facilities that have major cGMP problems. But last year, there was a major drop in FDA productivity for inspections and follow-ups. A recent FDA analysis found that FDA sent out only 70% […]
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How The US And FDA Can Reduce Medical Device Shortages
During the pandemic in 2020, FDA got new authority from Congress under the CARES Act to prevent shortages of medical devices. The CARES Act has language requiring medical device companies to give FDA information on device availability and when there may be possible disruptions of device availability during an emergency. Because of this new agency […]
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Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug
Antitrust officials in Italy fined a drugmaker almost $4 million last month for years of what they termed ‘excessive price hikes’ for a rare disease drug. This is the latest occurrence in Europe where regulators are dropping the hammer on pharmaceutical companies for allegedly overcharging customers. The medicine involved is called CDCA and is used […]
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FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped
In May, Novartis took the unusual step to stop production of two cancer therapies that rely on nuclear medicine to target various cancer cells. They also stopped clinical studies for one of the cancer treatments. Novartis said at the time that it was taking the step to be cautious to deal with possible cGMP issues […]
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FDA Needs To Do More To Prevent Food Shortages
In recent months, there has been a lot of attention devoted to the baby formula shortage gripping the US. Many in the regulatory industry have taken the FDA to task for not doing more to head off the problem sooner. When it comes to regulating pharmaceuticals and medical devices, the FDA has dealt more effectively […]
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National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials
The lack of diversity among patients in clinical trials is a serious issue that negatively affects those who have been left out of clinical studies, as well as the whole biomedical research field, according to a report issued this week by the National Academies of Sciences, Engineering, and Medicine. The report noted that there is […]
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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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