March 5, 2014 /PRNewswire-USNewswire/ -- Consumer Watchdog has confirmed that the Department of Public Health's Radiologic Health
Branch is investigating allegations that large amounts of soil dug up in a potentially radioactively contaminated parcel at Hunters Point may not have been checked for radiation before shipping to facilities not licensed to take low level radioactive waste.
Another problem is the apparent lack of coordination among the agency's three centers that regulate medical products--the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiologic Health
which leads to inconsistency in inspections.
Daniel Schultz, director of the FDA's Center for Devices and Radiologic Health
, decided to approve the device despite objections from other FDA staffers.
It never had to be moved for radiation, it only had to be moved for hazardous material,'' said Ed Bailey, DHS's radiologic health
The new regulations will not apply to private physician offices or other health care facilities that are not hospitals, said Barbara Zimmerman, a senior reviewer at the FDA's Office of Compliance at the Center for Devices and Radiologic Health
in Rockville, Md.
The laboratory will work closely with the FDA's five product centers: the Center for Drugs, Center for Biologics, Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine and the Center for Medical Devices and Radiologic Health
The new partnership will enable MCRA clients to benefit from an integrated approach to clinical trial design and implementation in response to changes issuing from regulatory bodies such as FDA's Center for Devices and Radiologic Health
One of the current study's co-authors is Thomas Gross, MD, MPH, director of the FDA's Office of Surveillance and Biometrics in the Center for Devices and Radiologic Health
According to Larry Spears of the FDA's Office of Compliance, Center for Devices and Radiologic Health
, the practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s.
Paul Baldenweg of the Radiologic Health
Branch at the California Department of Health Services inspected Ogden's business and found no evidence that radioactive material had leaked.
Food and Drug Administration (FDA) for a successful six-month evaluation by the Center for Devices and Radiologic Health
Such designation and assignment to the Center for Devices and Radiologic Health
has traditionally led to a faster regulatory and commercialization timeline for new products as compared to a combination product designated a drug.