Train for Pharma: Mediregs Pharmaceutical Library

The Pharmaceutical Regulation Library

The pharmaceutical business is one of the most highly regulated industries in the world. From lab bench to pharmacy shelf, a drug is subject to a strict set of testing, manufacturing, reimbursement, rebating and marketing regulations. MediRegs' Pharmaceutical Regulation Library (PRL) is dedicated to helping those responsible for pharmaceutical company compliance to stay on top of the complex web of regulatory materials governing the development and marketing of cosmetics, human and veterinary drugs and biologics. It is the central reference source for regulatory affairs professionals, lawyers, consultants and government officials in their daily decision-making on issues ranging from compliance with clinical trial requirements to post-marketing adverse event reporting.

What is the Pharmaceutical Regulation Library?

The Pharmaceutical Regulation Library is the ultimate research tool for finding answers to pharmaceutical compliance questions in the US. It provides, in a central location, thousands of documents, including:

Legislation - U.S. code and public laws
Code of Federal Regulations - updated continuously
Federal Register - FDA, CMS, OIG, PHS, HHS, FTC, DEA, CDC
FDA and NIH Manuals - including some not available on the web
FDA Guidelines - including some not available on the web, and searchable across FDA Centers
Advisory Committee Meeting Transcripts
Warning Letters, Court Cases, Consent Decrees and other enforcement materials
FDA Forms
FDA Press Releases, FOI Logs and other publications "hot off the press"
Monthly Product Approval Lists, the "Orange Book" and other product information
OTC Drug Monographs
OIG and GAO Reports relating to FDA
HIPAA and Medicare Moderization Act Information
ICD-9 Codes and other reimbursement information
Topic libraries with resources organized by subject)

The Pharmaceutical Regulation Library is available on the Internet, CD and DVD. The Internet version is updated daily and CD/DVD monthly.

Subscription to PRL includes daily email alerts of new information and access to the complete Federal Register back to 1991.