Document Types

On the PCX, you will have access to various laws, rules, and other government communications relating to regulatory compliance in the pharmaceutical industry. Each document on the PCX is accompanied by the following information: Document Type, Issuing Body, Date Published, and General Description.

We have posted various types of documents on this site. As stated in our Disclaimer, we are not providing any type of legal advice on this site. If you require clarification of any of the document types referenced on this site, please consult with your Legal Department or General Counsel, or retain outside counsel. Below is a list (in alphabetical order) of the document types you will encounter on this site, with a brief description of each.

Administrative Forms

Agencies typically create and provide administrative forms to manufacturers participating in regulated programs. These forms are administrative in nature.

Agency Rule

In the United States Federal Agency context, a "Rule" is defined by the Administrative Procedure Act ("APA") 554(1) as "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy describing the organization, procedure, or practice requirements, of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances there for or of violations, costs, or accounting, or practices bearing on any of the foregoing." Rules, assuming they have been properly enacted, have the force and effect of law. Rules are also commonly referred to as Regulations.

Case Law

In the United States, Case Law is established by judicial decisions in particular cases. We will provide relevant case law pertaining to various Federal Agencies and Programs. Please note that we will not be providing an exhaustive listing of case law, relative to an Agency or legal issue. Rather, any case law provided on this site is meant to be illustrative only. Should you have any legal questions, please consult with an attorney. As stated in our disclaimer, we are not providing any type of legal advice on this site; we are only providing and organizing public information relevant to Clinical R&D.

Directive (European Union)

A directive is a legislative act of the European Union which requires member states to achieve a particular result without dictating the method(s) of achieving that result. It can be distinguished from European Union regulations which are self-executing and do not require any implementing measures. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on its subject matter.

Federal Register Notice

United States Federal Agencies publish a number of things in the Federal Register, including: Presidential Documents (executive orders and proclamations), Rules and Regulations (policy statements and interpretations of rules by federal agencies), Proposed Rules (petitions by agencies for assistance in rulemaking and other proposals), Notices (scheduled hearings and meetings open to the public, grant applications, and administrative orders).

On this site, we will provide you with relevant Federal Register Notices and remove them when they become obsolete. For example, once a Rule has been codified in the Code of Federal Regulations, we will remove the original Federal Register Notice containing that Rule. Or, once a scheduled hearing or meeting open to the public has taken place, we will remove the Federal Register Notice pertaining to that scheduled event.

Guidance

A guidance document is a government document or communication issued by an Agency that explains or clarifies the law. Guidance typically does not carry the force and effect of law. However, insofar as Guidance explains a particular law, it is imperative to review, interpret, and use Guidance to comply with the law.

Regulation (European Union)

A Regulation is a legal instrument which has a general application, it is binding in its entirety and is directly applicable in all Member States. As 'Community laws', regulations must be complied with fully by those to whom they are addressed (individuals, Member States, Community Institutions). Regulations apply directly in all the Member States, without requiring a national act to transpose them, on the basis of their publication in the Official Journal of the European Community.

Statute

This could be either an Act of Congress, such as the FDA Amendments Act of 2007, or a provision of the United States Code, such as 21 USC355. Statutes are laws enacted by U.S.Congress (often signed into law or vetoed by the President).

Other

Some documents do not fit into any of the above categories and will be classified as "Other."

Disclaimer: As stated in our General Disclaimer, we are only providing public information, the decision of which to include or exclude was subjective on our part and based upon our experiences in the pharmaceutical Clinical R&D environment. Therefore, we do not and could not warrant that we have included every single piece of information on this site that you are required to be aware of and comply with in order to meet statutory or regulatory requirements. Additionally, given the voluminous nature of the documents and information contained on this site, we were required to categorize them in some manner, so as to make the site navigable and documents retrievable quickly. The categorization of documents, despite being done in a logical and consistent manner, is also a subjective process. Again, we are not providing legal advice on this site, and end users cannot rely upon anything contained herein as such.