Push for Modernization: The FDA Urged to Improve Recall Operations
Recent feedback suggests that the Food and Drug Administration (FDA) has room to modernize and improve its recall operations. In a listening session on September 30th, speakers from various backgrounds, including affected consumers and representatives of industry groups, unitedly voiced their concerns about the FDA's recall … [Read more...] about Push for Modernization: The FDA Urged to Improve Recall Operations
Baxter Issues Volara Recall; Respiratory Device May Cause Respiratory Distress
On June 1, 2022, Baxter International Inc. announced an Urgent Medical Device Correction for its Volara System (home care). This Volara recall was voluntary. Baxter inherited the Volara device when it acquired Hillrom for $12.5 billion. According to the U.S. Food and Drug Administration (FDA), Baxter voluntarily issued the Urgent … [Read more...] about Baxter Issues Volara Recall; Respiratory Device May Cause Respiratory Distress
Ukoniq Lawsuits
The FDA Withdraws Approval for Ukoniq (Umbralisib). On June 1, 2022, the U.S. Food and Drug Administration (FDA) withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns. Ukoniq had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL). According to the FDA, the risks … [Read more...] about Ukoniq Lawsuits
Philips Respironics Announces a New Recall Affecting its V60 Ventilator
Update: On June 3, 2022, the U.S. Food and Drug Administration (FDA) identified the Philips Respironics Recall for all V60 and V60 Plus Ventilators as a Class 1 recall, the most serious type of recall. According to an online news report on fingerlakes1.com, Philips Respironics has announced a new safety recall. The recall concerns … [Read more...] about Philips Respironics Announces a New Recall Affecting its V60 Ventilator
Ukoniq Lawsuits
The FDA Withdraws Approval for Ukoniq (Umbralisib). On June 1, 2022, the U.S. Food and Drug Administration (FDA) withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns. Ukoniq had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL). According to the FDA, the risks … [Read more...] about Ukoniq Lawsuits
FDA Virtual Inspections Might Endanger Americans
Do FDA “Virtual” Inspections of Domestic and Foreign Manufacturing Sites Endanger Americans? As the Covid-19 Pandemic Rages On, FDA is Issuing a Pilot Program for “Virtual” Inspections of Domestic and Foreign Manufacturing Sites UNITED STATES – According to medtech.pharmaintelligence.informa.com, the global pandemic is … [Read more...] about FDA Virtual Inspections Might Endanger Americans
New Federal Law May Grant the FDA the Power to Recall Dangerous Drugs
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is one step closer to receiving authority to order drug and medical device recalls. According to raps.org, the U.S. House of Representatives Committee on Appropriations voted to approve the FDA’s $3.212 billion budget that not only funds the agency for 2021 but also takes … [Read more...] about New Federal Law May Grant the FDA the Power to Recall Dangerous Drugs
FDA to End Alternate Summary Reporting Program
WASHINGTON D.C. — An article from CNN revealed that Medtronic’s Sprint Fidelis cardiac pacemaker and tens of thousands of other devices are exempt from public scrutiny because the FDA would permit medical device manufacturers to file summary reports of malfunctions rather than file full reports that would be made public by the … [Read more...] about FDA to End Alternate Summary Reporting Program
High Court Reviews Drug Lawsuit Preemption Case
Get Help From a Knowledgeable Defective Drug Lawyer Defective drugs are medications that cause physical or psychological injury. Often, these injuries relate to recalled drugs, drugs that were not adequately tested for all of their potential side effects, manufacturing errors, dosage mistakes, inadequate warnings, or mislabeling. If … [Read more...] about High Court Reviews Drug Lawsuit Preemption Case
FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
Defective Medtronic Heart Pump Is Taking Lives? Medtronic Life-Threatening Heart Devices. The Medtronic heart pump is an HVAD System which takes over for a failing heart. Basically, the system helps to support individuals with heart diseases while they wait for a heart transplant. Flaws, however, surfaced with the heart device … [Read more...] about FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
