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US FDA Lawyer Blog. Wednesday, January 21, 2015. FDA Releases Draft Guidances on Wellness Medical Devices and Accessories. The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories. In the draft guidance General Wellness: Policy for Low Risk Devices. The FDA states that it will not regulate. Treat or diagnose obesity;. Treat eating disorders, such as anorexia;. Help treat anxiety;.

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US FDA Lawyer Blog. Wednesday, January 21, 2015. FDA Releases Draft Guidances on Wellness Medical Devices and Accessories. The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories. In the draft guidance General Wellness: Policy for Low Risk Devices. The FDA states that it will not regulate. Treat or diagnose obesity;. Treat eating disorders, such as anorexia;. Help treat anxiety;.

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US FDA Lawyer Blog | usfdalawyer.blogspot.com Reviews

https://usfdalawyer.blogspot.com

US FDA Lawyer Blog. Wednesday, January 21, 2015. FDA Releases Draft Guidances on Wellness Medical Devices and Accessories. The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories. In the draft guidance General Wellness: Policy for Low Risk Devices. The FDA states that it will not regulate. Treat or diagnose obesity;. Treat eating disorders, such as anorexia;. Help treat anxiety;.

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usfdalawyer.blogspot.com

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US FDA Lawyer Blog: December 2013

http://usfdalawyer.blogspot.com/2013_12_01_archive.html

US FDA Lawyer Blog. Tuesday, December 24, 2013. FDA Issues Proposed Rules for Antiseptic Drug Products. The US. Food and Drug Administration (FDA) issued a new proposed rule. To amend its 1994 tentative monograph for OTC antiseptic drug products. The FDA is proposing to establish new conditions under which OTC consumer antiseptic products are generally recognized as safe and effective ("GRASE"). The new rule will be effective one year after it is finalized. After the effective date, all OTC consumer anti...

2

US FDA Lawyer Blog: FDA Issues Draft Guidance Regarding MDDS

http://usfdalawyer.blogspot.com/2014/06/fda-issues-draft-guidance-regarding-mdds.html

US FDA Lawyer Blog. Wednesday, June 25, 2014. FDA Issues Draft Guidance Regarding MDDS. The FDA has released draft guidance. Last Friday, stating that the agency considers medical device data systems (MDDS) to be safe and effective, and does not intend to regulate them. Facilitate electronic transfer or exchange of medical device data;. Store and retrieve medical device information, such as blood pressure data;. Convert medical device data from one format to another; and. Yi-Kang Hu, Ph.D., JD.

3

US FDA Lawyer Blog: April 2013

http://usfdalawyer.blogspot.com/2013_04_01_archive.html

US FDA Lawyer Blog. Tuesday, April 9, 2013. Freedom of Information Act Requester Scored Win at Federal Appeals Court. The US. Court of Appeals for the D.C. Circuit issued a major ruling last week preserving the rights of Freedom of Information Act (FOIA) requesters to proceed to court quickly when agencies don't comply with the legally required timelines to respond to demands for government records. Yi-Kang Hu, Ph.D., JD. Subscribe to: Posts (Atom). Freedom of Information Act Requester Scored Win at.

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US FDA Lawyer Blog: FDA Proposes Updates to Nutrition Facts Labels on Food Packages

http://usfdalawyer.blogspot.com/2014/02/fda-proposes-updates-to-nutrition-facts.html

US FDA Lawyer Blog. Thursday, February 27, 2014. FDA Proposes Updates to Nutrition Facts Labels on Food Packages. Several changes to the Nutrition Facts label for packaged foods today. The FDA also proposed to make corresponding updates to the Supplement Facts label on dietary supplements. Some of the changes. Being proposed by the FDA would:. Require information about the amount of "added sugar" in a food product. Remove "Calories from Fat" from the label. Update the format to emphasize certain elements.

5

US FDA Lawyer Blog: December 2011

http://usfdalawyer.blogspot.com/2011_12_01_archive.html

US FDA Lawyer Blog. Wednesday, December 28, 2011. FDA issues guidance for off-label communication. The FDA issued draft guidance. This week clarifying conditions under which drug and medical device makers may provide information on off-label uses. The draft guidance covers unsolicited requests for off-label information. An unsolicited request is one not initiated in any form by the drug or device maker (or its affiliates) itself. Information should be limited to the scope of the initial question. For a c...

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Spectra Law Group LLC | FDA Attorney Yi-Kang Hu, Ph.D. JD

http://www.usfdalawyer.com/about.html

Yi-Kang Hu, Ph.D., JD. Him for more information. Dr Hu developed his FDA law practice at a major global law firm, where he provided regulatory and intellectual property counsel to food, dietary supplement, drug, biologic, medical device, and cosmetic companies in the research, development, approval and promotion of their products in the U.S. and international markets. FDA Regulation of Medical Software Innovation. S Onel, C Pratt, YK Hu, K Nobert, ". Food and Drug Alert. Magazine, November/December 2006.

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Spectra Law Group LLC | FDA Attorney

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Spectra Law Group is dedicated to counseling and representing clients with respect to products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA). These products include foods, dietary supplements, cosmetics, medical devices, and pharmaceuticals. The firm for more information. FDA Finalizes Updates to Nutrition Facts and Supplement Facts Labels. FDA Issues Guidance to Clarify Requirements for Beverages v. Liquid Dietary Supplements. Website and Ad review. The cont...

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usfdalawyer.blogspot.com

US FDA Lawyer Blog

US FDA Lawyer Blog. Wednesday, January 21, 2015. FDA Releases Draft Guidances on Wellness Medical Devices and Accessories. The FDA issued two draft guidances on January 20 outlining its approach to regulating low-risk devices intended to promote general wellness as well as medical device accessories. In the draft guidance General Wellness: Policy for Low Risk Devices. The FDA states that it will not regulate. Treat or diagnose obesity;. Treat eating disorders, such as anorexia;. Help treat anxiety;.

usfdalawyer.com

Spectra Law Group LLC | FDA Attorney

Spectra Law Group is dedicated to counseling and representing clients with respect to products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA). These products include foods, dietary supplements, cosmetics, medical devices, and pharmaceuticals. The firm to arrange a free initial consultation. FDA Proposes Updates to Nutrition Facts and Supplement Facts Labels. FDA Issues Guidance to Clarify Requirements for Beverages v. Liquid Dietary Supplements. The content of...

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