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A recent guidance issued by the Centers for Medicare & Medicaid Services (CMS) has industry groups worrying about whether reimbursements for their products could be cut—or even eliminated.
The Global Harmonization Task Force (GHTF) has published two proposed guidance documents aimed at creating more uniform requirements for the design and review of clinical investigations involving medical devices.
The FDA July 25 posted an updated guidance answering common questions about humanitarian use devices (HUDs) and applications for humanitarian device exemptions (HDEs).
In hopes of meeting a 2006 goal that virtually all information given to patients to help them take prescriptions appropriately is useful, the FDA issued a guidance July 17 to help consumer medical information (CMI) developers meet the minimum criteria for useful information.
Analysts are projecting a sunny outlook for Abbott Laboratories based on 2006 second-quarter results — despite some company challenges.
At first glance, the company may seem to be faring worse than it actually is, said stock market website www.SeekingAlpha.com Editor Jonathan Liss.
In hopes of ensuring that virtually all information given to patients to help them take prescriptions appropriately is useful, the FDA issued a guidance July 17 to help consumer medical information (CMI) developers meet the minimum criteria for useful information.
The FDA published draft guidance June 19 to assist device manufacturers in preparing for FDA’s review of their premarket approval (PMA) applications and for coordinating inspections of PMA supplements.
The FDA’s Center for Biologics Evaluation and Research (CBER) earlier this month issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER’s Product Release Branch.
In hopes of meeting a 2006 goal that virtually all information given to patients to help them take prescriptions appropriately is useful, the FDA issued a guidance July 17 to help consumer medical information (CMI) developers meet the minimum criteria for useful information.