Food, Drug & Safety Laws Course

Subjects & Sources: Secondary Sources

   Law Review Articles & Treatises 

WestlawNext

 Selecting a Database

Click on Secondary Sources, then By Type, and then Law  Reviews and Journals

Searching

Note the keywords in each topic and think of synonyms such as

• SUDs for single use devices
• repeat use or re-use for Reuse
• unsanitary for dirty
• mistaken or harm for err

The following is a list of the agencies mentioned in these topics:

• Food and Drug Administration
• FDA Office of Criminal Investigations
• FDA Medical Device Safety
• FDA Medical Device Safety - Safety Communications
• Lawyers and Settlements - Food & Drink Law
• Center for Disease Control & Prevention - Foodborne Illness, Foodborne Disease, (sometimes called “Food Poisoning”)
• Center for Disease Control & Prevention -  Estimates of Foodborne Illness in the United States
• Center for Disease Control & Prevention - Food Related Diseases, Safety & Recalls
• Center for Disease Control & Prevention - Foodborne Outbreaks
• Association for the Advancement of Medical Instrumentation
• The American Hospital Association
• The Joint Commission of Health Care Organizations (JCAHO)
• European Union, European, Public Health, Medical Devices
• European Union Legal System

Lexis Advance

Selecting a Database

In the box with the red outline, click on Filters.  A large drop down box that has Jurisdiction, Category, Practice Area & Topic, Recent Favorites, and Advanced Search will appear.  Click on Practice Area and then on Administrative Law and Healthcare Law.

Searching

Use the keywords from the list of topics and their synonyms from Westlaw above for your first search. On the next page the results will be in the center and filters will be on the left. Filters include the type of source, search within results, jurisdiction, timeline, source, and others.  Type of source allows you to select cases, statutes, administrative rules, secondary sources and more. 

HeinOnline

Selecting a Database.

In the upper right hand corner, click on the red Login tab.  A list of all the databases will appear on the left-hand side.  The best one for secondary sources for this paper is the Law Journal Library. 

Searching  

The Advanced Search has a template with three blanks, menus for designating which field each blank will search, and a choice of Boolean and proximity operators.  Use the keywords from the list of topics and their synonyms from Westlaw above for your search.  Click on Help in the upper right to find out how to use truncation, proximity searching, and other powerful, advanced methods of searching.

 

Bloomberg Law

Bloomberg Law's secondary sources include Legal Analysis and News, Legal News, BNA Law Reports, BNA Portfolios, and BNA Manuals.  The Portfolios are short treatises; the Manuals are longer; and the Reports, Analysis and News are of the deep news kind.  They're all divided into chapters, sections and paragraphs and searchable.

Selecting a Database

Click on Legal Analysis and News on the horizontal orange bar to reveal the Law Reports, Manuals, Portfolios, and Legal News databases.  Under Legal Analysis and News, click on Search News for a sophisticated search template.

Searching

Use the keywords from the list of topics and their synonyms from Westlaw above for your search. 

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Cases, Codes,& Rules: Primary Sources

   Westlaw Cases

Topic and Keynumber

On the home screen under Browse click on the furthest right tab, Tools.  Then click on the first item, West Key Number System.  No matter what the subject of your paper, you will want to use 15A Administrative Law and Procedure and   You might also find the following useful:

• 157 Evidence
• 198H Health
• 198Hk600 - 899 Malpractice, Negligence, or Breach of Duty
• 198Hk975  Malpractice, Negligence, or Breach of Duty - In general
• 198Hk976 Malpractice, Negligence, or Breach of Duty - Constitutional and statutory provisions
• 198Hk982 Malpractice, Negligence, or Breach of Duty - Pharmaceuticals, drugs, and medical devices
• 198Hk 984 Malpractice, Negligence, or Breach of Duty - Records and duty to report
• 198Hk 986 Malpractice, Negligence, or Breach of Duty - Failure to provide adequate care 
• 198H989 Malpractice, Negligence, or Breach of Duty - Evidence
• 212 Injunction
• 272 Negligence

 

Selecting a Database

On the home screen under Browse click on Cases under All Content.  The search box at the top of the screen on the next page will search All Cases.  If you want a more specific database of cases, the choices are laid out below.

Searching

      Searching two topics:  to(15A) and to(198H)

      Searching a keynumber:  198Hk986

      Searching a topic and keynumber:  to(157) and 198Hk986

Searching the F.D.A. as a main topic of the cases and the topic, searches and seizures:  he,sy(fda or f.d.a.or "food and drug administration") and TO(349)

   Lexis Advance

        Selecting a Database

The three white tabs that are hanging beneath the horizontal red rectangle allow you to choose content types, jurisdictions and practice areas and topics. Under All Content Types, click on Cases, under All Jurisdictions choose whichever ones you want, and under Practice Areas and Topics, click on Administrative Law and whatever other one you want.

Searching

Use the keywords from the list of topics and their synonyms from Westlaw above for your first search.  Follow this one with a "search within results" for terms specific to the topic including the synonyms and the links to agencies and the Cook case listed above

 

HeinOnline

Selecting a Database.

In the upper right hand corner, click on the red Login tab.  A list of all the databases will appear on the left-hand side.  The best primary sources for this paper are the Code of Federal Regulations, Federal Register, U.S. Code , U.S. Congressional Documents, U.S. Federal Agency Documents, Decisions, and Appeals, and U.S. Statutes at Large.

Searching  

The Advanced Search has a template with three blanks, menus for designating which field each blank will search, and a choice of Boolean and proximity operators.  Use the keywords from the list of topics and their synonyms from Westlaw above for your search.  Click on Help in the upper right to find out how to use truncation, proximity searching, and other powerful, advanced methods of searching.

 

Bloomberg Law

Bloomberg Law has the same kind of primary sources as WestlawNext, Lexis Advance, and Hein do.

Selecting a Database

In the middle of Bloomberg's home page is a table of contents that lists All Legal Content, Court Opinions, Federal Law, State Law, and Dockets.  Each of them brings up a template for searching.  All Legal Content's template allows you to select the content that you want to search and create a search. 

Searching

Use the keywords from the list of topics and their synonyms from Westlaw above for your first search. 

 

Codes

 

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Other Laws Affecting FDA

Significant Amendments to the FD&C Act

Administrative Rules & Rule Making: Primary Sources

Rules & Regulations

CFR - Code of Federal Regulations Title 21

FDsys edition of the Code of Federal Regulations (Annual Edition)

FDsys edition of the Federal Register

Guidances

Treaties & IGOs

Treaties

International Conference on Harmonization (ICH) Guidance Documents

Treaties

 

IGOs

NGOs

Non-Governmental Organizations

There are several ways to find NGOs.  The following are some of the most reliable:

1. do a web search that includes terms like "NGO," and "nongovernmental organization" combined with a term for medical devices or similar subjects;
2. search for them in a database of non-profit organizations like Associations Unlimited (see a description below); or
3. look at the list of NGOs that have consultative status with the UN.
   

Associations Unlimited

Information about associations and professional societies, listings for nonprofit membership organizations of U.S. national, regional, state, and local, or international scope; in addition to 144,000 listings of the encyclopedia of associations (EA) series, nearly 300,000 additional nonprofit organizations have been added to this database.  It's coveratge is current.

 

Yearbook of International Organizations

The Yearbook of International Organizations provides the most comprehensive coverage of non-profit international organizations to date. The printed edition, published annually since 1948 and now in six volumes, and the online edition, published since 2000, consists of approximately 64,000 transnational civil society organizations in 300 countries and territories, and includes approximately 1,200 new entries each year.