Speaker Profile
Anna Longwell
Principal, Longwell and Associates
Anna Longwellis currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics.
They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.
Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC.
Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled "Due Diligence Points to Consider" in the "Expert's Guide to Healthcare Product Due Diligence" published by FDLI.
Ms. Longwell holds a bachelor's degree in Chemistry from San Francisco College for Women (now USF), a Master's degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).
A second look at 510(k) changes
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: ¤189.00 | View Details
The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
A second look at 510(k) changes
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
A second look at 510(k) changes
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA Think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think they Can Regulate them, and why do Others think they Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤190.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤290.00 | View Details
A second look at 510(k) changes
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
Laboratory-Developed Tests: Why does FDA Think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
FDA's Medical Device Clinical Trials Program
The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details
Laboratory-Developed Tests: Why does FDA think they Can Regulate them, and why do Others think they Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
Speaker: Anna Longwell | View Anytime | Price: ¤390.00 | View Details