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Regulatory Updates: Page 57
Tobacco firms sue FDA over cigarette labeling
By
DrBicuspid.com staff writers
Four major U.S. tobacco companies have filed a lawsuit against the U.S. Food and Drug Administration (FDA), challenging the agency's new graphic cigarette warnings as an unconstitutional way of forcing tobacco manufacturers to disseminate the government's antismoking message.
August 16, 2011
CODA to set standards for U.S. dental therapist programs
By
Donna Domino
The Commission on Dental Accreditation (CODA) has voted to set accreditation standards for dental therapy education programs in the U.S. The decision is in response to a request by the University of Minnesota, the first U.S. dental school to initiate such programs.
August 8, 2011
Mail-in device simplifies intraoral x-ray dose analysis
By
Kathy Kincade
Almost every state in the U.S. requires a periodic assessment of all radiographic equipment in a dental, medical, or hospital setting. Now a novel device for evaluating the image quality and patient dose of intraoral x-ray systems is gaining favor among radiation protection agencies and dental offices alike.
August 3, 2011
OCO Biomedical gains Health Canada OK for implants
By
DrBicuspid.com staff writers
Dental implant manufacturer OCO Biomedical has received approval from Health Canada for the sale of class II dental implants.
July 31, 2011
IOM report hits FDA 510(k) program, offers solutions
By
Wayne Forrest
After 16 months of research, the Institute of Medicine (IOM) has released a report that concludes the U.S. Food and Drug Administration's 510(k) program "lacks the statutory basis to make a reliable premarket screen for safety and effectiveness of class II medical devices."
July 28, 2011
FDA clarifies 510(k) device modification rules
By
DrBicuspid.com staff writers
The U.S. Food and Drug Administration has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
July 25, 2011
Oral bisphosphonates may up risk of esophageal cancer
By
DrBicuspid.com staff writers
The U.S. Food and Drug Administration is continuing to review data from published studies to evaluate whether the use of oral bisphosphonates is associated with an increased risk of esophageal cancer.
July 20, 2011
FDA mulls regulatory oversight of mobile medical apps
By
DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is seeking input on a proposal to provide oversight of certain mobile applications specific to medicine or healthcare designed for use on smartphones and other mobile computing devices.
July 18, 2011
FTC judge rules that NC dental board acted illegally
By
Donna Domino
A U.S. Federal Trade Commission (FTC) judge has ruled that the North Carolina dental board's efforts to block nondentists from providing teeth-whitening services constitute an illegal anticompetitive conspiracy.
July 18, 2011
P&G recalls 2 mouthwashes in Canada
By
DrBicuspid.com staff writers
Procter & Gamble is conducting a voluntary recall of two mouthwash products in Canada due to possible microbial contamination.
July 13, 2011
Irish regulators update dental x-ray position statements
By
DrBicuspid.com staff writers
The Radiological Protection Institute of Ireland has published two new position statements for users of dental x-ray equipment that amend its Code of Practice for Radiological Protection in Dentistry.
July 7, 2011
WHO wants more graphic warnings to cut smoking
By
Reuters Health
LONDON (Reuters) - More than a billion people in 19 countries are now covered by laws requiring large, graphic health warnings on tobacco packs, but too many countries are still not doing enough to cut smoking rates, the World Health Organization said on Thursday.
July 7, 2011
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