Tag:
draft guidance
Latest Headlines
Latest Headlines
Roche's Tarceva wins NICE nod for first-line use
After an initial draft guidance rejecting the lung cancer treatment, the National Institute for Health and Clinical Excellence now says Tarceva should be available as a first-line treatment.
FDA looks to improve the representation of women in device studies
The FDA has issued a draft guidance to address the underenrollment of women in medical device clinical trials. The agency says the objectives of the guidance are to better communicate the balance of
FDA looks to clarify benefit-risk determinations for medical devices
The FDA today has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance, which focuses on PMAs, is intended to
FDA may change premarket notification requirements for radiology devices
The FDA has issued a draft guidance that shows it may relax premarket notification requirements for certain in vitro diagnostic and radiology devices. The draft lists 30 device types, including
FDA looks to reduce exposure to improperly reprocessed devices
The FDA is taking steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to disease transmission. Reprocessing is a multi-step process that includes cleaning,
