FDA
Sales Restriction on Essure Birth Control Device
Restricting the sale of the Essure birth control device. As announced in an April 9, 2018 Release, the U.S. Food and Drug Administration (FDA), has issued an order restricting the sale of the Essure birth control device and requiring additional risk information to be shared with patients. The Essure device, manufactured by Bayer, has … [Read more...] about Sales Restriction on Essure Birth Control Device
Powdered Medical Gloves Ban Takes Effect January 19, 2017
The FDA Are Banning The Use Of Powdered Medical Gloves.On December 19, 2016, the Food and Drug Administration (FDA) published the final rule banning the use of powdered gloves in health care because exposure to the gloves poses "unreasonable and substantial risk of illness or injury." The rule goes into effect on January 19, 2017, … [Read more...] about Powdered Medical Gloves Ban Takes Effect January 19, 2017
FDA 23andMe Warning over DNA Testing Service Sold
FDA Issues Warning to 23andMe The U.S. Food and Drug Administration (FDA) is seeking to stop all sales and marketing of a DNA testing product that appears to be more of a medical device than a consumer product. The FDA is seeking to stop consumer sales of 23andMe's genetic testing products until approval is obtained. The agency … [Read more...] about FDA 23andMe Warning over DNA Testing Service Sold
FDA to Study Animation in Drug Ads
Role in Obscuring Vital Safety Information. The U.S. Food and Drug Administration (FDA) is beginning an investigation into the effects of animation and cartoons in advertising in consumers. The study will investigate the reactions of people to animated ads as well as ads featuring live human actors and observe how the … [Read more...] about FDA to Study Animation in Drug Ads
Soft Tissue Filler Injected into Blood Vessel Injury Risk
Soft Tissue Filler Suspected Of Injury Risk. The Food and Drug Administration (FDA) has issued a safety communication warning of the risk of injury if soft tissue fillers—also known as dermal fillers, wrinkle fillers, or injectable facial implants—are accidentally injected into a blood vessel. The FDA issued the alert to warn … [Read more...] about Soft Tissue Filler Injected into Blood Vessel Injury Risk
Long-Term Anti-platelet Therapy Risks
FDA Evaluating A Clinical Trial About Risk From Anti-platelet Therapy. On November 16 the Food and Drug Administration (FDA) announced that it is evaluating preliminary data from a clinical trial showing an increased overall risk of death for patients treated for 30 months with dual anti-platelet blood-thinning therapy … [Read more...] about Long-Term Anti-platelet Therapy Risks
Clinic that implants Lap-Band devices gets warning
Clinic That Implants Lap-Band Devices Gets FDA Warning. People who might visit oBand Centers near Marina Del Rey, Calif., are not getting enough information on the potentially dangerous risks associated with a Lap-Band surgery offered through these facilities. According to an MMM-Online.com report, the Food and Drug … [Read more...] about Clinic that implants Lap-Band devices gets warning
No Conclusion From FDA on Possible SSRI Antidepressant
FDA can't Answer the Question Taking SSRI during Pregnancy. The U.S. Food & Drug Administration (FDA) still can't answer the question of whether taking selective serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy may increase the risk that a baby will be born with pulmonary hypertension of the newborn … [Read more...] about No Conclusion From FDA on Possible SSRI Antidepressant
FDA Criticized Over Heart Device Trials
Journals accused the FDA of releasing some devices to market based on inadequate test results that are “open to bias." The U.S. Food and Drug Administration (FDA) has been criticized by two prominent medical journals over how it approves cardiovascular medical devices, says the Wall Street Journal. The journals accused the FDA of … [Read more...] about FDA Criticized Over Heart Device Trials
Negative Pressure Wound Therapy Warning From FDA
Negative Pressure Wound Therapy Systems. The use of Negative Pressure Wound Therapy systems have been associated with deaths and serious complications, the U.S. Food & Drug Administration (FDA) warned yesterday. In a health alert posted on its Web site, the FDA said it will continue to monitor adverse events associated … [Read more...] about Negative Pressure Wound Therapy Warning From FDA
Menaflex Approval Influenced by Political Pressure, FDA Report Says
Influenced by political pressure A report from the Food & Drug Administration (FDA) says the agency caved to political pressure when it approved ReGen Biologics Inc.'s Menaflex knee device. According to The Wall Street Journal, the FDA is now reconsidering its approval of Menaflex. Menaflex is meant to repair a torn … [Read more...] about Menaflex Approval Influenced by Political Pressure, FDA Report Says
FDA Enlists External Review of Device Approval Process
FDA Commission On Approval Process The U.S. Food and Drug Administration (FDA) just announced it commissioned the Institute of Medicine (IOM) to study the pre-market notification program used to review and clear certain medical devices marketed in the United States. The study will examine the program, also called the 510(k) … [Read more...] about FDA Enlists External Review of Device Approval Process
FDA Proposes Mandatory E-Reporting of Adverse Events
The Food & Drug Administration (FDA) has proposed two new regulations aimed at improving access to and analysis of safety information provided by the medical product industry. The two proposed rules will apply to the FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) and … [Read more...] about FDA Proposes Mandatory E-Reporting of Adverse Events
FDA Warns Certain Glucose Test Strips May Yield False Results
Glucose Test Strips May Produce False Results. Federal health regulators are warning that GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose meters or test strips should never be used by anyone who is being treated with drug products or therapies that contain certain sugars other than glucose. According to the Food … [Read more...] about FDA Warns Certain Glucose Test Strips May Yield False Results
Accuracy of Home Glucose Meters Questioned
FDA Questions Accuracy of Home Glucose Meters. U.S. health regulators are considering tougher standards for the home glucose monitors that millions of diabetics rely on. The Food & Drug Administration's (FDA) decision to reconsider the standards was prompted by a request from a prominent doctors' group. Home glucose monitors … [Read more...] about Accuracy of Home Glucose Meters Questioned
Arthroscopic Shavers Subject of FDA Safety Alert
Medical Device Subjected To Review Arthroscopic shavers, devices that are used in some orthopedic surgical procedures, are being subjected to a Food & Drug Administration (FDA) safety review. According to the agency, there have been reports of instances in which pieces of tissue have remained within certain arthroscopic shavers, … [Read more...] about Arthroscopic Shavers Subject of FDA Safety Alert
Drug Industry Supports FDA Splitting Decision
drug industry is hoping for an FDA split President Obama Repair A Broken FDA. As President Barack Obama takes steps to repair a broken U.S. Food and Drug Administration (FDA), the drug industry is hoping for an FDA split. The Associated Press (AP) is breaking with the news that, amid continuing and newly emerging food borne illness … [Read more...] about Drug Industry Supports FDA Splitting Decision
President Obama Nominates Former NY Health Chief for FDA Head
President Obama's Choice To Head FDA Has Been Announced. President Barack Obama’s long-awaited choice to head the ailing U.S. Food and Drug Administration (FDA) has been announced. Reuters reported that President Obama has nominated Margaret Hamburg, 53, the former New York City health commissioner, to the post. The New York Times … [Read more...] about President Obama Nominates Former NY Health Chief for FDA Head
FDA Faulted Again for Oversight of Medical Devices
Safety Of Medical Device Scrutiny. Labs that develop medical devices haven't been receiving adequate scrutiny from the Food & Drug Administration (FDA), a new report says. According to the Project on Government Oversight (POGO), the FDA's Center for Devices and Radiological Health (CDRH) allows manufacturers and … [Read more...] about FDA Faulted Again for Oversight of Medical Devices
Another GAO Report Faults FDA
FDA failed To Protect Americans. In a recent government report, the U.S. Food and Drug Administration (FDA) has been found incapable of fully protecting Americans. Congress’s U.S. Government Accountability Office (GAO) released its findings yesterday saying that the FDA is, according to Reuters, “hampered by increasing globalization … [Read more...] about Another GAO Report Faults FDA
FDA Instructed to Strengthen Medical Device Reviews
Agency told to impose tougher measures. The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says. According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier … [Read more...] about FDA Instructed to Strengthen Medical Device Reviews
FDA Scientist Urges Obama to Fix Corrupt Agency
Obama urged to Stop corruption. FDA Is Rife With Corruption. It’s confirmed. The Food & Drug Administration (FDA) is rife with corruption. A number of media outlets just broke the news that some scientists at the FDA wrote to President-Elect Barack Obama’s transition team basically begging for help and outlining a number of … [Read more...] about FDA Scientist Urges Obama to Fix Corrupt Agency
FDA Alerts About Complications with Surgical Mesh
Surgical Mesh Linked To Complications. Download FDA Update on the Serious Complications Associated with TVM. The Food & Drug Administration (FDA) recently warned that surgical mesh used in gynecologic surgery to treat pelvic organ prolapse and stress urinary incontinence had been linked to serious complications. As we've … [Read more...] about FDA Alerts About Complications with Surgical Mesh
Charges of Corruption in FDA Medical Device Approvals
Probe on FDA medical device approval gets tough. A letter from scientists and physicians at the Food & Drug Administration (FDA) has charged that the agency has corrupted the process by which new medical devices are approved, Bloomberg.com reports. The letter was sent to Democratic Representative John Dingell, Chairman … [Read more...] about Charges of Corruption in FDA Medical Device Approvals
Obama Presidency Sparks Hope for a New, Improved FDA
Obama Presidency Hopes For New Improved FDA. Obama Presidency Lobbying For Strong New FDA. With a Barack Obama presidency just months away, both industry representatives and consumer groups are lobbying for strong new leadership at the Food & Drug Administration (FDA). Both groups believe that such leadership could restore … [Read more...] about Obama Presidency Sparks Hope for a New, Improved FDA
Cutting Cables on BOLS System Can Cause Explosion
Federal Regulators have Warned That Cutting Cables on BOLS System Can Cause Explosion. Federal regulators have warned that cutting the cable on disposable battery-operated lavage systems (BOLS) can cause toxic fumes, sparks, fires, and explosions. BOLS devices are used to provide pulsed irrigation for the removal of … [Read more...] about Cutting Cables on BOLS System Can Cause Explosion
Lawmakers Want Oversight of Imported Medical Devices and Cosmetics
Imported Medical Devices More Oversight. Democratic lawmakers say the US Food and Drug Administration (FDA) has insufficient funding and power to maintain appropriate oversight and regulation of products, especially medical devices and cosmetics. "While the market for these products becomes increasingly global, the FDA has … [Read more...] about Lawmakers Want Oversight of Imported Medical Devices and Cosmetics
Senate Panel Assails FDA Funding
FDA does not have adequate funding “to adequately protect the nation". According to this week’s bipartisan Senate panel meeting, the US Food and Drug Administration (FDA) does not have adequate funding “to adequately protect the nation's increasingly global supply of food and drugs.” The lawmakers confirmed that the FDA needs … [Read more...] about Senate Panel Assails FDA Funding
Group Urges FDA Medical Device Tracking Program
FDA Medical Device Tracking Program. The Food & Drug Administration (FDA) is taking too long to announce and implement a program to track medical devices, a coalition of health care advocacy groups said. Implementation of an identification system that assigns a medical device unique number will mean quicker and more … [Read more...] about Group Urges FDA Medical Device Tracking Program
FDA Reviews Safety Notification Procedures
FDA Review Safety Notification Procedures. The U.S. Food and Drug Administration (FDA) is looking at how it tells the public about safety concerns with foods, prescription drugs, medical devices, and other products it regulates, the agency's commissioner said on Thursday. "How we communicate what we do is as important as … [Read more...] about FDA Reviews Safety Notification Procedures
Lack of FDA Inspectors Negatively Impacts Consumers
Heightened tracking of medical products urged. A top drug safety official told lawmakers on Wednesday that the US Food and Drug Administration (FDA) needs more inspectors and a comprehensive computer database to better track products entering the US from the burgeoning group of drug manufacturers, brokers, and distributors currently … [Read more...] about Lack of FDA Inspectors Negatively Impacts Consumers
Defective Medical Devices Show Need for More Regulation
Authorities Mull Regulation Against Defective Medical Devices. Defective medical devices like Stryker hip implants, Medtronic Defibrillators and the Kugel Mesh Hernia Patch have injured countless people. Now researchers from the University of California, San Francisco (UCSF) have asserted that medical devices are not … [Read more...] about Defective Medical Devices Show Need for More Regulation
FDA Budget Increase Falls Short of Expectations
FDA Budget Increase Unstable. Proposed FDA Budget Increase Announced By President Bush. The proposed Food and Drug Administration (FDA) budget increase announced yesterday by President Bush won’t do much to improve the agency’s performance. Under the new budget, the FDA - which regulates 80% of the nation's food, drugs, vaccines, … [Read more...] about FDA Budget Increase Falls Short of Expectations
FDA Targets Dangerous Fake Medical Device
FDA To Go After Fake Medical Device. Fake medical devices have finally gotten the attention of federal regulators. In a collaborative move with foreign governments, the Food and Drug Administration (FDA) is taking steps to stop manufacturers who import fraudulent, and often, dangerous medical devices into the United States, … [Read more...] about FDA Targets Dangerous Fake Medical Device
Unretrieved Device Fragments Linked to 1000 Injuries Every Year, FDA Warns
Unretrieved Device Fragments Of A Medical Device. Unretrieved Device Fragments are causing serious injuries to patients, the Food & Drug Administration (FDA) reported today. According to the FDA public health advisory, an Unretrieved Device Fragment is a fragment of a medical device that has separated unintentionally … [Read more...] about Unretrieved Device Fragments Linked to 1000 Injuries Every Year, FDA Warns
Ban Unproven ‘Energy Medicine’ Devices
Unproven Energy Medicine Devices Have Injured Many People in America. Unproven medical devices have injured many people in the United States, yet the Food & Drug Administration (FDA) has not moved aggressively to protect consumers from these unsafe – and often illegal – devices. Now, officials from the state of Washington have … [Read more...] about Ban Unproven ‘Energy Medicine’ Devices
FDA Enforcement Actions Fall, Yet Violation Reports Haven’t
FDA Enforcement Actions Fall. Food and Drug Administration enforcement actions targeting safety problems, quality lapses and misleading claims have fallen sharply even though violations have not, according to statistics released Monday by Rep. Henry A. Waxman (D-Los Angeles). In 2005, FDA headquarters issued 535 warning … [Read more...] about FDA Enforcement Actions Fall, Yet Violation Reports Haven’t
Device to Combat Depression Was Approved Despite Evidence of Its Effectiveness
FDA may soon approve a vagus nerve stimulator made by Cybertronics. On May 24, 2005, newsinferno.com reported that: “Although many experts maintain there is little evidence that the device actually works, the FDA may soon approve a ‘vagus nerve stimulator’ manufactured by Cybertronics, Inc., for the treatment of severe … [Read more...] about Device to Combat Depression Was Approved Despite Evidence of Its Effectiveness
FDA: 22% of Follow-Up Studies On Medical Devices Go Undone
FDA-Required Medical Devices Study Failed. Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio. "It's not a pretty picture," Daniel G. Schultz, director … [Read more...] about FDA: 22% of Follow-Up Studies On Medical Devices Go Undone
FDA Reviews Boston Scientific Acid Reflux Device After Death
Death After Treated with a Boston Scientific Corp. Acid Reflux Device. The Food and Drug Administration is reviewing the death last month of an elderly woman after she was treated with a Boston Scientific Corp. device for acid reflux disease. The FDA is also looking at injuries in six other patients treated with the Enteryx … [Read more...] about FDA Reviews Boston Scientific Acid Reflux Device After Death
FDA Shuts Gas Facility Operations
Large medical gas provider violated a court order. The Food and Drug Administration has shut down certain operations of a large medical gas provider, saying it violated a court order to correct safety violations. At issue is the Coatesville, Pa., branch of Air Liquide America Corp. The FDA said that facility hauled different … [Read more...] about FDA Shuts Gas Facility Operations
FDA OK of Stomach Band Premature, Researchers Say
Stomach Band Was Cleared. An adjustable stomach band used for treating severe obesity was cleared prematurely by the US Food and Drug Administration (FDA) and may not be as safe as previously thought, according to researchers who conducted a four-year study of the product. The inflatable banding system, called the … [Read more...] about FDA OK of Stomach Band Premature, Researchers Say
