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Regulatory Updates: Page 34
FDA tightens rules for e-cigarettes
By
Donna Domino
The U.S. Food and Drug Administration (FDA) has issued new rules that extend federal regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco. It is also the first time federal law has prohibited retailers from selling e-cigarettes, hookah tobacco, or cigars to people younger than 18 years old.
May 16, 2016
Vigilant gets CE Mark for 2nd oral cancer test
By
DrBicuspid.com staff writers
Vigilant Biosciences' OncAlert oral cancer rapid test has received the CE Mark, which allows the company to market the test in Europe.
May 3, 2016
Calif. approves bill on pediatric sedation oversight
By
Donna Domino
California lawmakers have approved a bill to increase oversight of pediatric sedation during dental procedures after a 6-year-old boy died while under general anesthesia for an extraction in 2015.
April 20, 2016
Second Opinion: ADA supports competition, except in dentistry
By
Dr. Steven Krauss
In this Second Opinion, Dr. Steven Krauss asks an important question about healthcare insurance, competition, and the ADA's approach to both. Dr. Krauss wonders why competition is important in one area and not in others.
April 18, 2016
FDA clarifies approach toward Interleukin perio test
By
DrBicuspid.com staff writers
Interleukin Genetics announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) that clarifies the agency's regulatory approach toward its PerioPredict genetic test for periodontic disease.
April 14, 2016
FDA to review Merck's Keytruda for head/neck cancer
By
DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has granted priority review designation to Merck's Keytruda (pembrolizumab) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
April 14, 2016
Texas governor appoints new dental board examiners
By
DrBicuspid.com staff writers
Texas Gov. Greg Abbott has named a new chair of the state's Board of Dental Examiners, as well as appointed or reappointed six examiners.
March 31, 2016
FTC sues opioid manufacturer, other pharma companies
By
DrBicuspid.com staff writers
The U.S. Federal Trade Commission (FTC) has filed a complaint in federal district court that alleges Endo Pharmaceuticals and other companies blocked consumers' access to lower-cost generic versions of two pain medications, including an opioid.
March 30, 2016
LED Dental gets FDA OK for Tuxedo digital radiography system
By
DrBicuspid.com staff writers
LED Dental has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tuxedo digital intraoral radiography system.
March 29, 2016
BioRed launches Total Compliance service
By
DrBicuspid.com staff writers
Regulated medical waste return company BioRed has launched a new Total Compliance service to meet updated Occupational Safety and Health Administration compliance rules.
March 28, 2016
Sonendo gets FDA clearance for new GentleWave system
By
DrBicuspid.com staff writers
Endodontic technology developer Sonendo has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next generation of its GentleWave system.
March 28, 2016
FTC weighs in on Ky. denturists bill
By
DrBicuspid.com staff writers
The Federal Trade Commission (FTC) has commented on proposed legislation in Kentucky that would license and regulate denturists in the state.
March 27, 2016
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