Pharmaceutical Development Group, Inc. (PDG) was founded in 1999 by Dr. Cheryl Blume and has quickly become a leading consultant to the pharmaceutical industry. Headquartered in Tampa, Florida, PDG provides a wide variety of regulatory and pharmaceutical consulting services to organizations of all sizes, both foreign and domestic.

As a complimentary resource, PDG has assembled a collection of valuable FDA links for your reference and use. If you would like to contribute a link or learn more about PDG and our services, please click on PDG or go directly to contact us.

FDA Links:
Approvals/Labels (primarily drugs; see device database below for devices)

Approvals/Labels (primarily biologics; see device database below for devices)


Citizen Petitions (Dockets)

Compliance Policy Guides

Device Database

Enforcement/Recalls/Alerts (primarily biologics)

Enforcement/Recalls/Alerts (primarily devices)

Enforcement/Recalls/Alerts (primarily drugs)

Enforcement/Recalls/Alerts (may apply to biologics, devices and drugs)

Guidances (CBER/primarily biologics)

Guidances (CDER/primarily drugs)

Guidances (CDRH/primarily devices)

Federal Register

Medical Product Safety Information

New Postings to CDER

Orange Book

OTC Monographs

Unapproved Drugs

User Fees

Warnings/Untitled Letters

American Association of Pharmaceutical Scientists:
American Pharmacists Association:
American Society for Clinical Pharmacology and Therapeutics:
Drug Information Association:
Generic Pharmaceutical Association:
Regulatory Affairs Professional Society:
The Academy of Pharmaceutical Sciences:

PDG consists of a multidisciplinary team of scientists whose mission is to provide professional product development consulting services and the development of winning regulatory strategies for the pharmaceutical industry. PDG's competencies include pharmaceutical development across the spectrum of prescription, OTC, generic, and innovator drug products, biologic products, and devices. Our expertise as a pharmaceutical consultant and regulatory consultant is equally wide-ranging and designed to meet your needs from the single research project to the development of a comprehensive regulatory strategy for U.S. and international product launches.

Copyright 2009 Pharmaceutical Development Group, Inc.