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FDA Regulatory law, in-vitro diagnostic regulatory law | Longwell & Associates

Longwell & Associates is a Palo Alto-based law firm that specializes in assisting health care product and medical technology companies in dealings with the FDA to bring their products to market. We have over 40 years of combined experience in regulatory law, are registered patent attorneys and holders of patents, and are located in the heart of Silicon Valley’s dynamic and innovative medical technology community. Our core value to our clients is our accessibility coupled with our knowledge. We see your busi

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FDA Regulatory law, in-vitro diagnostic regulatory law | Longwell & Associates | fdclaw.com Reviews
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Longwell & Associates is a Palo Alto-based law firm that specializes in assisting health care product and medical technology companies in dealings with the FDA to bring their products to market. We have over 40 years of combined experience in regulatory law, are registered patent attorneys and holders of patents, and are located in the heart of Silicon Valley’s dynamic and innovative medical technology community. Our core value to our clients is our accessibility coupled with our knowledge. We see your busi
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FDA Regulatory law, in-vitro diagnostic regulatory law | Longwell & Associates | fdclaw.com Reviews

https://fdclaw.com

Longwell & Associates is a Palo Alto-based law firm that specializes in assisting health care product and medical technology companies in dealings with the FDA to bring their products to market. We have over 40 years of combined experience in regulatory law, are registered patent attorneys and holders of patents, and are located in the heart of Silicon Valley’s dynamic and innovative medical technology community. Our core value to our clients is our accessibility coupled with our knowledge. We see your busi

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Practice Areas | Longwell & Associates

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Food and Drug Law Product Offerings. A Law Practice specializing in Food and Drug Law. For New Ventures in Health Care. Assess Regulatory Options, US and Global:. For any new medical product, drug or device, the first question is always; “Will it work? 8221; As soon as the answer is “maybe”, you should consider regulatory options for testing and marketing product. Often, the most obvious regulatory pathway may not be the optimal one. Contract drafting, review, and consultation. The information contained ...

2

Compliance | Longwell & Associates

http://fdclaw.com/compliance

By Anna Longwell, Esq. Medical Device Compliance Note:. Recalls, Removals and Corrections, and Medical Device Reporting. Combination Product Clinical Trials. The information contained in this site is for general information only, and is not legal or regulatory advice about the compliance of any activity with current law or regulation. Website Design by Tierra Interactive.

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People | Longwell & Associates

http://fdclaw.com/people

Anna Longwell, Esq. Robert Longwell, Esq. The information contained in this site is for general information only, and is not legal or regulatory advice about the compliance of any activity with current law or regulation. Website Design by Tierra Interactive.

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International | Longwell & Associates

http://fdclaw.com/international

Website for EU Study. Medicinal sites, EU. Website for EU Study. Http:/ www.europa.eu.int/eur-lex/en/index.html. Europa – the European Union Online. Http:/ europa.eu.int/. Http:/ europa.eu.int/eur-lex/en/index.html. Enterprise Medical Devices Guidelines. Http:/ europa.eu.int/comm/enterprise/medical devices/guidelinesmed/baseguidelines.htm. Belgian Competent Authority (CA). Http:/ health.fgov.be/. UK CA, devices. Http:/ www.medical-devices.gov.uk. Http:/ www.mca.gov.uk. German CA, drugs and devices. Inter...

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News | Longwell & Associates

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Tobacco Products Scientific Advisory Committee (TPSAC) meeting 3-1-2012. On March 1st, 2012, the Tobacco Products Scientific Advisory Committee met to finalize their report on dissolvable tobacco products, and their impact in several areas including public health and on children’s health. Background: The TPSAC is an advisory panel within the FDA that was created by the Family Smoking Prevention and Tobacco Control Act (Public [.]. Summary of Hematology and Pathology Devices Panel Meeting.

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DayOne came to us to build a new website from the ground up in collaboration with their graphic designer. This is the original Homepage, which launched around Thanksgiving of 2010. About a year later, the company decided that they wanted a directional change to their website. They came to us for a redesign, which lauched in December 2011 (next slide). The new Homepage features:. Workshops and Classes schedules and registration. Blog and Video highlights. Class and Workshop Registration. Needed a friendly...

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FDA Regulatory law, in-vitro diagnostic regulatory law | Longwell & Associates

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