FDA Encourages Pediatric Drug Studies

The U.S. Food and Drug Administration is using its authority under laws passed by Congress in order to encourage and promote pediatric drug studies. The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) are laws passed by Congress to increase pediatric drug testing. Prior to BPCA and PREA, 80 percent of drugs given to children were only tested as safe and effective on adults. That number has been reduced to 50% and the goal is to reduce that further. As an…
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FDA Releases New Guidelines for Oversight of Clinical Trials

This past week, the Food and Drug Administration released Guidance for Industry on “Oversight of Clinical Investigations – A Risk-Based Approach.”  The purpose of the Guidance is to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical studies of medical devices, human drug and/or biological products. While these guidelines are not mandatory, they do reflect the FDA’s thinking on the topic and are certainly industry-based recommendations. In this new Guidance, the FDA describes strategies that reflect a modern, risk-based approach…
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Additional Battery Testing for Medical Devices Recommended By FDA

On July 30 and 31, the Food and Drug Administration conducted a Battery-Powered Medical Devices Workshop to create awareness and address challenges associated with use of battery-powered medical devices. At the workshop, the FDA addressed the increasing number of adverse events linked to batteries in medical devices. While the FDA is confident that medical devices currently being marketed will continue to function appropriately, according to the agency, there are opportunities to further improve their design, overall performance and safety. Batteries play a significant role in…
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FDA To Require New Warnings on Drugs Containing Acetaminophen of Serious Skin Reactions

The Food and Drug Administration is going to require warning labels be added to prescription drugs containing acetaminophen based on the drug’s association with rare skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP).  The FDA will also be asking manufacturers of over the counter drug products containing acetaminophen to warn about serious skin reactions. The FDA’s action was based on a review of the FDA Adverse Event Reporting System database and the existing medical literature.  The…
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Voluntary Recall of Millions of Glucose Test Strips

On July 31, 2013, the FDA announced a voluntary recall of Nova Max Glucose Test Strips.  It is estimated that approximately 62 million strips may be affected and are marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.  The test strips, manufactured between December 2011 and April 2013, were contaminated with a chemical during the manufacturing process.  This chemical causes false readings indicating a false, abnormally high blood glucose level.  This could result in an insulin…
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European Medicines Agency Issues New Restrictions on Reglan

On July 26, the European Medicines Agency (EMA) announced new restrictions on medications containing metoclopramide, known generally by the brand name Reglan, in the most recent development based upon potential neurological side effects related to use of this medication. Use of metoclopramide increased significantly in the 1990s after its predecessor, Cisapride, was found to cause serious side effects. By 2004, however, research began to suggest that use of metoclopramide was potentially related to a movement disorder known as tardive dyskinesia. Symptoms of tardive dyskinesia may…
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Litigation Concerns Rise as FDA Proposes Reclassification of Tanning Beds

The Food and Drug Administration (FDA) issued a press release regarding its proposed order to reclassify sunlamp products from a Class I medical device (low risk) to a Class II medical device (moderate risk).  Additionally, the FDA is now recommending that persons under the age of 18 be warned to not use these products at all. The FDA press release notes that “[a]ccording to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin…
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FDA Encouraging Hackers to Submit Medical Device Cybersecurity Flaws

On June 13, 2013, the Food and Drug Administration issued a safety communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and biomedical engineers advising them to take steps to secure cybersecurity for medical devices and hospital networks.  The FDA warned that as medical devices are increasingly interconnected, via the internet or wireless devices, there is an increased risk of  cybersecurity breaches, which could affect how a medical device operates. The FDA advised that it has become aware of cybersecurity vulnerabilities…
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HHS Proposes to Undo the Supreme Court Rulings in Pliva and Bartlett by Regulation Changes

In 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which affected “75 percent of all prescription drugs dispensed in this country.”  The court held that because the FDA requires generic drug manufacturers to use the same labels and warnings as those of the name-brand manufacturer, state law claims against generic companies regarding labeling and warnings are pre-empted. Put another way, because generic drug manufacturers cannot change their labels or warnings, even if they later learn of additional risks associated…
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Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…
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