Hair loss is often a depressing signature of chemotherapy, particularly disturbing for women who have to undergo treatment. One way to help prevent hair loss during chemo sessions is to cool the scalp, narrowing blood vessels around hair follicles and slowing the uptake of the poison in the area.
The Food and Drug Administration is sending a strong message to pharmaceutical companies. Make potent prescription pain killers “unmeltable,” “uncrushable” and hard to abuse – or face having the product pulled from the market. But even more significant is the push now to find ways to deal with chronic pain without using addictive drugs at all.
Apple’s iOS App Store has drawn lots of criticism for strict policies that the company forces developers to accept when creating apps for the iPhone and iPad. The criticism is particularly frustrating when the company appears to enforce its mandates inconsistently and capriciously. These bans can have far-reaching consequences. That’s definitely the case for the most recent spate of app rejections. Identified by iMedicalApps, Apple has been rejecting medical and health apps that provide information about prescription and over-the-counter medications. The rulings appear to target drug reference guide apps that provide both on- and off-label dosage guidelines. In rejecting these apps, Apple has cited a section in its developer requirements that states that the company will only accept dosing instructions within an app if that app is being produced by a drug’s manufacturer. Apps that provide dosing schedules or guidelines for medications that are not created by drug makers are subject to rejection.
As modern medical advances help more children with complex conditions live longer, a new study shows a significant number suffer from complications caused by medical devices that are also necessary for their survival.
The US Food and Drug Administration (FDA) is touting the 20th anniversary of one of its most essential safety reporting tools, MedWatch, which it uses to collect adverse event reports about pharmaceuticals, medical devices and other FDA-regulated products, allowing it to monitor risks to consumers and take action when necessary. And now FDA is announcing something else: a consumer-focused MedWatch reporting form.
FDA analysis: 510(k) is here to stay, says Medtech attorney; The FDA’s 510(k) “substantial equivalence” test for medical device review is strong, safe and here to stay, according to an analysis by medtech attorney Jeffrey Shapiro.
Got a gripe with an older draft guidance document? Now might be the time to air that grievance, with the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announcing that it plans to conduct a retrospective analysis of all guidance documents issued prior to 2010 with the intent of withdrawing unnecessary documents or revising any documents in need of changes.
Device makers object to FDA’s proposed recall guidance; Medical device titan Boston Scientific and industry lobbying group AdvaMed respond to the FDA’s latest draft guidance on medtech recalls, warning that the new language may cause more confusion than it clears.
Heart device approval delays leave US doctors frustrated; Americans accustomed to immediate access to the newest technology may be shocked to find that is not the case when it comes to devices that treat ailing hearts. U.S. approval requirements for cardiac devices are much more stringent than in Europe, where there is no centralized decision-making body. But a growing number of U.S. heart doctors feel the regulations are so demanding that patients are being denied access to beneficial therapies.
An international study involving 255 physicians practicing in Vancouver, Montreal, Sacramento and Toulouse found that physicians are not given enough information about the adverse effects of drugs during presentations made by medical sales representatives from pharmaceutical companies. And yet, these same physicians are willing to prescribe at least some of the presented drugs.