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)
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Approvals/Labels (primarily biologics; see device database below for devices)
http://www.fda.gov/cber/products.htm

CFRs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Citizen Petitions (Dockets)
http://www.fda.gov/ohrms/dockets/default.htm
http://www.regulations.gov/search/index.jsp

Compliance Policy Guides
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/

Device Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm

Enforcement/Recalls/Alerts (primarily biologics)
http://www.fda.gov/cber/recalls.htm
http://www.fda.gov/cber/safety/safety.htm

Enforcement/Recalls/Alerts (primarily devices)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm
http://www.fda.gov/cdrh/safety.html

Enforcement/Recalls/Alerts (primarily drugs)
http://www.fda.gov/cder/warn/
http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm

Enforcement/Recalls/Alerts (may apply to biologics, devices and drugs)
http://www.fda.gov/oc/enforcement.html
http://www.fda.gov/opacom/enforce.html
http://www.fda.gov/opacom/7alerts.html
http://www.fda.gov/foi/warning.htm
http://www.fda.gov/ora/frequent/default.htm
http://www.fda.gov/medwatch/safety.htm

Guidances (CBER/primarily biologics)
http://www.fda.gov/cber/guidelines.htm

Guidances (CDER/primarily drugs)
http://www.fda.gov/cder/guidance/

Guidances (CDRH/primarily devices)
http://www.fda.gov/cdrh/guidance.html

Federal Register
http://www.fda.gov/ohrms/dockets/FDMS/SubmissionInformation.htm

Medical Product Safety Information
http://www.fda.gov/medwatch/safety.htm

New Postings to CDER
http://www.fda.gov/cder/whatsnew.htm

Orange Book
http://www.fda.gov/cder/ob/default.htm
http://www.fda.gov/cder/orange/default.htm

OTC Monographs
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm

Unapproved Drugs
http://www.fda.gov/cder/drug/unapproved_drugs/default.htm
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#enforcement

User Fees
http://www.fda.gov/oc/oms/ofm/userfees/userfees.htm

Warnings/Untitled Letters
http://www.fda.gov/cder/ddmac/lawsregs.htm#Enforcement%20Actions
http://www.fda.gov/foi/warning.htm


PDG MEMBERSHIP LINKS:
American Association of Pharmaceutical Scientists: www.aapspharmaceutica.com
American Pharmacists Association: www.pharmacist.com
American Society for Clinical Pharmacology and Therapeutics: www.ascpt.org
BioFlorida: www.bioflorida.org
Drug Information Association: www.diahome.org
Generic Pharmaceutical Association: www.gphaonline.org
Regulatory Affairs Professional Society: www.raps.org
The Academy of Pharmaceutical Sciences: www.apsgb.co.uk


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.