Category: Regulations
-
What Does Mumbai Death Mean For The Future Of MRI Testing?
In reality, the MRI machine itself is quite safe. Issues only occur when you introduce other metals into the mix.
-
Spin-Off Gains FDA Clearance for Bone Graft Material
A company spun-off from a university tissue engineering research lab received clearance from the Food and Drug Administration to market its polymer material in the U.S. to help regrow bones.
-
Agencies Send Warnings to Halt Opioid Cessation Scams
Two federal agencies sent warning letters to companies the agencies say are illegally marketing products making false or unsubstantiated claims about their treating opioid addiction or withdrawal.
-
Little Data to Support Wearable Device Health Benefits
A review of published research since 2000 shows little evidence to support claims of beneficial health outcomes from the use of wearable devices like smart watches or wristbands, at least not yet.
-
FDA to Release More Accessible Clinical Trial Data
The U.S. Food and Drug Administration plans to make available in a more user-friendly format details from clinical trials of new drugs approved by the agency.
-
FDA Clears Targeted Breast Cancer Radiation Treatment
The U.S. Food and Drug Administration approved a device that sends high doses of radiation to cancerous breast tissue while sparing healthy tissue nearby.
-
FDA Approves Gene Therapy for Inherited Vision Loss
A therapy using transfers of healthy genes to treat a rare form of inherited vision loss was approved today by the U.S. Food and Drug Administration.
-
FDA Issues Draft Precision Medicine Trial Guidance
The U.S. Food and Drug Administration issued draft regulatory guidance on clinical trials for new treatments that target genetic mutations rather than disease states.
-
FDA Fast-Tracks Heart Failure Gene Therapy
A biotechnology company developing transfers of healthy genes to treat chronic diseases is receiving an accelerated review of its heart failure therapy from the U.S. Food and Drug Administration.
-
Current Drug Helps Cut Opioid Use After Surgery
Results from a clinical trial show patients given a current non-opioid pain medication with different types of surgery were less likely to use opioids for up to a year later.