Food and Drug Administration - Revision history

WikiModEn2: Wikify.

2022-10-30T19:29:34Z

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	[[Image:fda-logo.jpg\|right\|thumb]]		[[Image:fda-logo.jpg\|right\|thumb]]

	The American Food and Drug Administration has approved several circumcision devices and products made from harvested infant foreskins.<ref name='fda-accucirc'>{{REFweb		The American Food and Drug Administration has approved several [[circumcision]] devices and products made from harvested infant [[Foreskin\| foreskins]].<ref name='fda-accucirc'>{{REFweb
	\|last=Brogdon		\|last=Brogdon
	\|first=Nancy C.		\|first=Nancy C.

WikiAdmin: wikify skin

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	\|accessdate=2011-03-06		\|accessdate=2011-03-06
	}}</ref><ref name='fda-dermagraft-tc'>{{REFweb		}}</ref><ref name='fda-dermagraft-tc'>{{REFweb
	\|quote=...fibroblast-derived temporary skin substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA.		\|quote=...fibroblast-derived temporary [[skin]] substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA.
	\|last=		\|last=
	\|first=		\|first=

WikiAdmin: using UNI template

2021-12-13T19:59:05Z

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	\|Text=Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.		\|Text=Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.

	Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the University of California, San Francisco. She said it's those lenient federal standards that are the problem.		Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the {{UNI\|University of California\|UCSF}}, San Francisco. She said it's those lenient federal standards that are the problem.

	"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."		"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."

WikiAdmin: wikify amputation

2021-11-13T11:10:34Z

wikify amputation

← Older revision		Revision as of 11:10, 13 November 2021
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	== Circumcision Injury Reports ==		== Circumcision Injury Reports ==
	As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews		As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile [[amputation]] and urethral damage.<ref>{{REFnews
	\|last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\|first=Molly		\|first=Molly

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2021-11-09T19:08:54Z

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	{{REF}}		{{REF}}

	[[Category:~~Organizations~~]]		[[Category:Organization]]

	[[Category:From CircLeaks]]		[[Category:From CircLeaks]]

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2019-11-21T20:59:37Z

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Show changes

WikiAdmin: Fixed date format error.

2019-11-04T06:40:07Z

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← Older revision		Revision as of 06:40, 4 November 2019
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	\|publisher=Los Angeles Times		\|publisher=Los Angeles Times
	\|quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice...		\|quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice...
	\|accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews		\|accessdate=2011-09-25
			}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews
	\|last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\|first=Molly		\|first=Molly
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	\|publisher=Los Angeles Times		\|publisher=Los Angeles Times
	\|quote=Instead of recalling the devices, the FDA advised users to make sure...		\|quote=Instead of recalling the devices, the FDA advised users to make sure...
	\|accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews		\|accessdate=2011-09-25
			}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews
	\|last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\|first=Molly		\|first=Molly
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	\|publisher=Los Angeles Times		\|publisher=Los Angeles Times
	\|quote=The agency also cautioned against using replacement parts on the Gomco clamp...		\|quote=The agency also cautioned against using replacement parts on the Gomco clamp...
	\|accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews		\|accessdate=2011-09-25
			}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews
	\|last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\|first=Molly		\|first=Molly
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	\|publisher=Los Angeles Times		\|publisher=Los Angeles Times
	\|quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports...		\|quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports...
	\|accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews		\|accessdate=2011-09-25
			}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews
	\|last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\|first=Molly		\|first=Molly
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	\|publisher=Los Angeles Times		\|publisher=Los Angeles Times
	\|quote=Twenty-one of those reports were related to Mogen clamps...		\|quote=Twenty-one of those reports were related to Mogen clamps...
	\|accessdate=2011-09-25}}</ref>		\|accessdate=2011-09-25
			}}</ref>

	== Products & Devices ==		== Products & Devices ==
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	\| last=		\| last=
	\| first=		\| first=
	\| date=~~March~~ 2012		\| date=2012-03
	\| title=Report Slams Approval Process for Medical Devices		\| title=Report Slams Approval Process for Medical Devices
	\| url=http://www.webcitation.org/66VuXY3Us		\| url=http://www.webcitation.org/66VuXY3Us
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	\| last=		\| last=
	\| first=		\| first=
	\| date=~~July~~ 2012		\| date=2012-07
	\| title=FDA Conducted Surveillance Operation Against Scientists		\| title=FDA Conducted Surveillance Operation Against Scientists
	\| url=http://www.webcitation.org/69DN3PuxD		\| url=http://www.webcitation.org/69DN3PuxD
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	\|last=		\|last=
	\|first=		\|first=
	\|date=~~December~~ 2011		\|date=2011-12
	\|title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430)		\|title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430)
	\|url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf		\|url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf
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	\| last=		\| last=
	\| first=		\| first=
	\| date=~~June~~ 2012		\| date=2012-06
	\| title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470)		\| title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470)
	\| url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf		\| url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf

WikiAdmin: remove parameter

2019-10-19T21:07:40Z

remove <coauthors> parameter

← Older revision		Revision as of 21:07, 19 October 2019
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	== Circumcision Injury Reports ==		== Circumcision Injury Reports ==
	As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews		As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews
	\| last=Hennessy-Fiske		\|last=Hennessy-Fiske
	\| first=Molly		\|first=Molly
	~~\| coauthors=~~		\|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story
	\| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story		\|title=Injuries linked to circumcision clamps
	\| title=Injuries linked to circumcision clamps		\|date=2011-09-26
	\| date=2011-09-26		\|publisher=Los Angeles Times
	\| publisher=Los Angeles Times		\|quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice...
	\| quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice...		\|accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews
	\| accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews		\|last=Hennessy-Fiske
	\| last=Hennessy-Fiske		\|first=Molly
	\| first=Molly		\|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story
	~~\| coauthors=~~		\|title=Injuries linked to circumcision clamps
	\| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story		\|date=2011-09-25
	\| title=Injuries linked to circumcision clamps		\|publisher=Los Angeles Times
	\| date=2011-09-25		\|quote=Instead of recalling the devices, the FDA advised users to make sure...
	\| publisher=Los Angeles Times		\|accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews
	\| quote=Instead of recalling the devices, the FDA advised users to make sure...		\|last=Hennessy-Fiske
	\| accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews		\|first=Molly
	\| last=Hennessy-Fiske		\|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story
	\| first=Molly		\|title=Injuries linked to circumcision clamps
	~~\| coauthors=~~		\|date=2011-09-25
	\| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story		\|publisher=Los Angeles Times
	\| title=Injuries linked to circumcision clamps		\|quote=The agency also cautioned against using replacement parts on the Gomco clamp...
	\| date=2011-09-25		\|accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews
	\| publisher=Los Angeles Times		\|last=Hennessy-Fiske
	\| quote=The agency also cautioned against using replacement parts on the Gomco clamp...		\|first=Molly
	\| accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews		\|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story
	\| last=Hennessy-Fiske		\|title=Injuries linked to circumcision clamps
	\| first=Molly		\|date=2011-09-26
	~~\| coauthors=~~		\|publisher=Los Angeles Times
	\| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story		\|quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports...
	\| title=Injuries linked to circumcision clamps		\|accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews
	\| date=2011-09-26		\|last=Hennessy-Fiske
	\| publisher=Los Angeles Times		\|first=Molly
	\| quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports...		\|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story
	\| accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews		\|title=Injuries linked to circumcision clamps
	\| last=Hennessy-Fiske		\|date=2011-09-26
	\| first=Molly		\|publisher=Los Angeles Times
	~~\| coauthors=~~		\|quote=Twenty-one of those reports were related to Mogen clamps...
	\| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story		\|accessdate=2011-09-25}}</ref>
	\| title=Injuries linked to circumcision clamps
	\| date=2011-09-26
	\| publisher=Los Angeles Times
	\| quote=Twenty-one of those reports were related to Mogen clamps...
	\| accessdate=2011-09-25}}</ref>

	== Products & Devices ==		== Products & Devices ==
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	On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities.<ref>{{REFweb		On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities.<ref>{{REFweb
	\| last=		\|last=
	\| first=		\|first=
	\| date=December 2011		\|date=December 2011
	\| title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430)		\|title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430)
	\| url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf		\|url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf
	\| publisher=		\|publisher=
	\| accessdate=2011-12-16		\|accessdate=2011-12-16
	}}</ref> The report read in part:		}}</ref> The report read in part:

WikiAdmin: remove parameter

2019-10-16T12:38:22Z

remove <coauthors> parameter

← Older revision		Revision as of 12:38, 16 October 2019
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	\| accessdate=2011-03-06		\| accessdate=2011-03-06
	}}</ref><ref name='fda-tns'>{{REFjournal		}}</ref><ref name='fda-tns'>{{REFjournal
	\| last=		\|last=
	\| first=		\|first=
	~~\| coauthors~~=		\|date=
	\| date=		\|title=About SkinMedica
	\| title=About SkinMedica		\|journal=SkinMedica Brochure
	\| journal=SkinMedica Brochure		\|volume=
	\| volume=		\|issue=
	\| issue=		\|pages=
	\| pages=		\|url=http://www.skinbrands.co.uk/SkinMedica_Brochure.pdf
	\| url=http://www.skinbrands.co.uk/SkinMedica_Brochure.pdf		\|quote=The cell banks used for NouriCel-MD™ (the key ingredient in SkinMedicaʼs TNS Cosmeceuti- cal product range) is already used in TransCyte™ and Cosmoderm Cosmoplast (Human Collagen) a dermal filler marketed by Allergan ‒ both FDA approved.
	\| quote=The cell banks used for NouriCel-MD™ (the key ingredient in SkinMedicaʼs TNS Cosmeceuti- cal product range) is already used in TransCyte™ and Cosmoderm Cosmoplast (Human Collagen) a dermal filler marketed by Allergan ‒ both FDA approved.		\|accessdate=2011-05-12
	\| accessdate=2011-05-12
	}}</ref>		}}</ref>

WikiAdmin at 18:23, 20 September 2019

2019-09-20T18:23:51Z

← Older revision		Revision as of 18:23, 20 September 2019
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	\| first=		\| first=
	\| coauthors=		\| coauthors=
	\| ~~pubyear~~=		\| date=
	\| title=About SkinMedica		\| title=About SkinMedica
	\| journal=SkinMedica Brochure		\| journal=SkinMedica Brochure