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France issues stricter rules for pharma trials

lab_franceThe French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and hospitalized five others in January. France’s health minister Marisol Touraine presented a plan on Monday for stricter rules regarding human drug trials. The plan also requested the Rennes-based Biotrial CRO that conducted the trial to submit a “plan of action” within a month to explain how it will avoid a repeat of these or else lose its operating license.

The report, issued by France’s General Inspectorate of Social Affairs (IGAS), also calls on the government to “mobilize the international scientific community” to find out what went wrong and suggests a range of scientific approaches, such as testing whether the drug hits other brain targets than the intended one and a study of the potential toxicity of the compound’s metabolites. Read more…

New insurance template for Swiss clinical trials

October 2, 2015 Leave a comment

clinicalTrialsThe Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now requires the insured risk be categorized as category A, B, or C as outlined by Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) of September 20, 2013 (Status as of January 1, 2014). Insurers do not have the descriptions for the classifications, and are prohibited from providing advice regarding categorization of a trial. Sponsors or their CROs must seek advice from the Swiss Ethics Committees on research involving humans to determine the appropriate classification for their trial. Categorization of the trial is required before the certificate of insurance meets the requirements of the Human Research Act (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) can be issued. Certificates cannot be issued without the categorization of the Insured risk. Read more…

The increasing necessity for product recall insurance

Blue Bell Creameries of Brenham, Texas made the decision to voluntarily recall all of its products on after two chocolate chip cookie dough ice cream samples tested positive for Listeria, a potentially fatal bacteria. The extensive recall includes ice cream, sherbet, frozen yogurt, and other frozen snacks distributed in 23 states and internationally. This development comes after Blue Bell issued a more limited recall in March after the Centers for Disease Control and Prevention (CDC) connected ice cream contaminated with Listeria to three deaths in Kansas. The Center for Disease Control and Prevention confirmed that 10 people in total from four states have contracted Listeria as a result of this outbreak.
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FDA delays generic drug label warning update

December 11, 2014 Leave a comment

fdaThe U.S. Food and Drug Administration’s final rule on generic drug label warning regulations won’t be published until late next year, according to last month’s announcement from the federal agency. Since late 2013, FDA officials have collected feedback on a proposal to grant generic drug manufacturers permission to update product labels independently with new safety information without having to wait until the brand-name counterpart drug makes similar changes. Due to intense interest and a great deal of public input from various industry groups, the FDA pushed the decision back from this month until September 30th, 2015. The proposal has ignited heavy debate between plaintiff’s lawyers and the pharmaceutical industry, since the decision would overturn the U.S. Supreme Court’s 2011 ruling in Pilva v. Mensing, which limited the liability of generic manufacturers. Under the Mensing decision, generic drug labels are required to match brand name products, which shields generic makers from failure-to-warn suits since they have little control over what safety information is provided to patients. Read more…

New EU med device legislation targets safety, improved coordination

In an effort to re-vamp medial device regulations, the European Commission (EC), the executive body of the European Union responsible for proposing legislation, unveiled new legislation aimed at strengthening the safety of products and better coordination between the Commission and it’s Member States. While the European Union’s (EU) lenient product regulations often make it the first market for new medical devices, a 2012 scandal involving defective breast implants from a French manufacturer prompted the EC to re-examine it’s standards. While some safety measures have been successfully implemented since the scandal, EC officials felt the need for further action, acknowledging that “some key improvements . . . require a reinforced legal basis.” In response, the EC has developed a new action plan introducing several changes to the laws in order to improve product safety and consumer confidence. Earlier this month, the Employment, Social Policy, Health Read more…

FDA suggests social media standards for pharma and med device companies

fda_twitterThe FDA issued a pair of guidelines on Tuesday for pharmaceutical and medical device companies regarding the use of social media and internet communication for medical products. While other industries, including financial services , retail and real estate have immersed themselves in using social media as a marketing tool,  pharmaceutical companies have been slower to embrace the trend, due to strict regulatory and privacy laws. But as technology continues to drive consumer and patient behavior – a 2013 study found that one in four interactions with doctors, healthcare professionals and patients in the U.S. is digital – the FDA recognizes a need to adapt to these changes and in turn, establish industry best practices for social media use. The long-awaited guidance aims to provide consumers with more accurate, accessible information online, and proposes guidelines for pharmaceutical and medical device companies about how to correct misinformation posted online by others. Read more…

Medical device recalls jump over last decade

April 17, 2014 Leave a comment

medicaldeviceRecent reports from the FDA’s Center for Devices and Radiological Health (CDRH) indicate that medical device recalls have nearly doubled (about 97%) since 2003. The Medical Device Recall Report, released last month, analyzed data from the last decade showing the number of recalls, as well as why the products had been pulled from the market. The report looked specifically at devices like ventilators, infusion pumps and external defibrillators, all of which have been historically linked to device failures, such as batter problems or improper device maintenance.

CDRH officials say that while the report’s data may appear alarming, the jump in recalls may be a good thing. The increase reflects industry efforts to improve the quality and safety of medical devices, which has resulted in a greater number of recalls reported. Manufacturers who were cited for violations in the past have an improved understanding of their products, Read more…