Regulatory Updates: Page 40

MiMedx comments on FDA draft guidance
By DrBicuspid.com staff writers
Regenerative medicine company MiMedx Group has commented on a draft guidance from the U.S. Food and Drug Administration (FDA) regarding cell- and tissue-based products.
December 30, 2014
Levin on the patient perspective; Oregon and SDF; regulatory issues in transactions
By Tony Edwards
December 28, 2014
Regulatory hot spots in dental transactions: Part 2
By Barton C. Walker, LauraLee Lawley, and John Saran
In this Second Opinion, a partner and two associates from healthcare law firm McGuireWoods continue their series on regulatory issues in dental transactions, focusing on dental service organizations (DSOs) and considerations such as noncompete clauses, billing procedures, and HIPAA compliance.
December 28, 2014
2013 12 23 15 23 25 385 Second Opinion 200
FDA's reclassification of SDF as a fluoride could mean new treatment options
By Donna Domino
The Oregon dental board's resolution allowing dental auxiliaries to apply silver diamine fluoride (SDF), which followed the recent classification of SDF as a fluoride by the U.S. Food and Drug Administration, could mean new treatment options, especially for Medicaid beneficiaries.
December 25, 2014
2014 09 04 16 45 47 306 Tooth Caries 200
Aspen Dental to pay nearly $1M over deceptive advertising claims
By DrBicuspid.com staff writers
Dental chain Aspen Dental has agreed to pay $990,000 to settle allegations of deceptive advertising and marketing practices and also failing to give refunds to consumers for services not provided in Massachusetts, according to the state attorney general.
December 21, 2014
Denti-Cal not delivering for kids; Levin on production; potential DSO regulatory issues
By Tony Edwards
December 21, 2014
Regulatory hot spots in dental transactions: Part 1
By Barton C. Walker, LauraLee Lawley, and John Saran
In this Second Opinion, a partner and two associates from healthcare law firm McGuireWoods detail the potential regulatory issues in dental transactions, focusing on dental service organizations (DSOs). They stress that due diligence is needed to determine if all federal and state laws have been followed.
December 21, 2014
2013 12 23 15 23 25 385 Second Opinion 200
FDA: Relief ACP oral care gel recalled
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) announced that Relief ACP oral care gel was voluntarily recalled by manufacturer Discus Dental because of an "incorrect composition of ingredients." The company mistakenly filled the gel product with hydrogen peroxide teeth-whitening gel, which made it ineffective or could cause increased sensitivity.
December 18, 2014
FDA approves Gardasil 9 vaccine for 9 HPV types
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has approved the Gardasil 9 vaccine for preventing certain diseases caused by nine types of human papillomavirus (HPV).
December 10, 2014
Zimmer proposes package to win EC approval of Biomet deal
By DrBicuspid.com staff writers
Zimmer Holdings has proposed a remedy package to the European Commission (EC) to facilitate the EC's approval of Zimmer's proposed acquisition of Biomet.
December 4, 2014
Texas court invalidates rules on Medicaid payment holds
By Donna Domino
A Texas appeals court has invalidated several rules related to payment holds imposed during Medicaid fraud investigations, saying they violate due process rights. The decision sides with plaintiffs Harlingen Family Dentistry and Trueblood Dental Associates and also reverses a trial court's ruling.
December 1, 2014
2013 11 18 17 15 05 637 Gavel 200
FTC urges accreditation standards for dental therapy programs
By DrBicuspid.com staff writers
U.S. Federal Trade Commission (FTC) staff today submitted comments to the Commission on Dental Accreditation (CODA), urging CODA to finalize and adopt accreditation standards for dental therapy education programs.
November 30, 2014
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