The U.S. Food and Drug Administration (FDA) has halted inspections of drugs and medical devices manufactured overseas. According to the FDA, the decision is due to the spread of the novel coronavirus, COVID-19. First, the FDA pulled back inspections in China, but has since pulled back from other countries, including...
Roche Coronavirus Test Receives Emergency Use Authorization from the FDA
Medical device manufacturer, Roche Diagnostics, has received emergency use approval (EUA) from the U.S. Food and Drug Administration (FDA) for their Cobas SARS-CoV-2 coronavirus test. The test detects the virus COVID-19 through nasopharyngeal or oropharyngeal swab samples. The test can be used in patients who meet clinical or epidemiological testing...
Drug Manufacturers Developing Vaccines and Treatments for Coronavirus
The number of coronavirus (COVID-19) cases in the United States continues to rise. As more communities suffer infection, quarantines and general panic, researchers continue to learn whatever they can about how the virus spreads, who is most at risk and how the virus could be prevented. Drug manufacturers are among...
Cybersecurity Warnings Issued for GE Healthcare Medical Devices
The U.S. Food and Drug Administration (FDA) has issued a device safety alert for GE Healthcare medical devices. The safety alert relates to GE Healthcare Clinical Information Central Stations and Telemetry Servers. The FDA says that cybersecurity threats could risk the health of the patients that these medical devices monitor...
More Antacid Recalls Issued due to Trace Elements of NDMA
On the heels of notable recent medication recalls like Zantac, the U.S. Food and Drug Administration (FDA) is recalling even more medications due to possible trace elements of NDMA. NDMA (Nitrosodimethylamine) is a probable human carcinogen, meaning it may cause cancer. The presence of NDMA in Zantac has made waves...
Investigation Continues in Lung Injury Outbreak Related to E-Cigarettes
The investigation into the ongoing lung injury outbreak continues, with the focus remaining on e-cigarette use as the culprit. The Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and various local and state health departments are joining forces to continue the investigation. The lung injury...
Medication Safety Questioned as FDA Investigates More NDMA Claims
With Valsartan and Zantac still making headlines due to possible carcinogenic contamination, it is no surprise that medication safety is being questioned by the masses. But it is also being questioned by agencies like the U.S. Food and Drug Administration (FDA). As the investigation into Zantac continues, the FDA is...
Secret Cache of Medical Device Complaints Spurs Lawsuits and Research
In June, we told you about the U.S. Food and Drug Administration’s (FDA) secret database that effectively hid millions of medical device injury complaints. In our post titled “The FDA Comes Clean About Millions of Injuries Caused by Medical Devices,” we touched on the fact that six million reports of...
How Does Vaping Affect Your Body?
E-cigarettes are incredibly popular, especially with teenagers and young adults. While it is touted as being a safer alternative to traditional cigarettes, e-cigarette use, or vaping, is not without risk. According to the Centers for Disease Control and Prevention (CDC), e-cigarette use may actually be more dangerous than other tobacco products. ...
FDA Answers Questions about Ranitidine (Zantac) Recall
News sources across the United States have reported on the recall of popular antacid medication Zantac (ranitidine). The U.S. Food and Drug Administration’s (FDA) recall notice warns patients and healthcare providers that certain Zantac and ranitidine products manufactured by Apotex Corp. may be contaminated with N-nitrosodimethylamine (NDMA). Consequently, the FDA...
News Update: JUUL CEO Steps Down, Ends Merger Talks with Philip Morris
At Drug and Device Watch, we continue to follow reports of illness and addiction related to JUUL brand e-cigarettes. Most recently in the news is the fact that JUUL’s CEO has stepped down. The new CEO is an executive at Altria Group Inc., the company that owns 35 percent of...
What Parents Need to Know about Vaping Related Illness
Across the country, hundreds of victims are reporting vaping related illness. What is most alarming is that most of the cases involve young adults or teens. Health officials say the illnesses among these groups is a troubling sign of increased use in this demographic. Some are now calling the increase...