Information regarding requesting and preparing for formal meetings with the FDA
http://www.fda.gov/cber/gdlns/mtpdufa.htm
The most common initial meeting with the FDA is a pre-IND meeting (21 CFR 312.82).

Additional information regarding the scheduling and conduct of formal meetings
http://www.fda.gov/cber/regsopp/81011.htm

Information on Submitting an Investigational New Drug Application (IND) for a Biological Product: http://www.fda.gov/cber/ind/ind.htm  This link includes the following applicable regulations and more.

The IND regulations contained in 21 CFR Part 312 http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr312_07.html

The informed consent regulations at 21 CFR Part 50 http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr50_07.html 

The Institutional Review Board (IRB) regulations at 21 CFR Part 56 http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr56_07.html

Human Subject Protection – Information for Institutional Review Boards, Clinical Investigators, and Sponsors
http://www.fda.gov/oc/ohrt/irbs/ These guidance documents provide recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in research regulated by FDA.

HHS Policy for Protection of Human Subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Human Participant Protections Education for Research Teams
http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

This free, web-based course presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants.  It satisfies the NIH human subjects training requirement for obtaining Federal Funds.

List of guidance documents related to submission of INDs
http://www.fda.gov/cber/ind/indpubs.htm

FDA Regulations Relating to Good Clinical Practice and Clinical Trials
http://www.fda.gov/oc/gcp/regulations.html

FDA regulations on the exportation of investigational new drugs, including biological products
[70 Federal Register at 70,720 (Nov. 2005)]
http://www.fda.gov/cber/rules/indexpreq.htm

General information regarding the FDA regulation of Cellular and Gene Therapies
http://www.fda.gov/cber/gene.htm

Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)
http://www.fda.gov/cber/genadmin/octgtprocess.htm

FDA Expectations for INDs for Cellular and Gene Therapy
http://www3.niaid.nih.gov/research/topics/radnuc/PDF/McFarland.pdf

Gene Therapy Clinical Trials Observing Subjects for Delayed Adverse Events
http://www.fda.gov/cber/gdlns/gtclin.pdf

NIH guidelines for research involving recombinant DNA molecules (NIH guidelines) April 2002
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

Compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html

Office of Biotechnology Activities (OBA) home page
http://www4.od.nih.gov/oba

Recombinant DNA Advisory Committee (RAC) webpage
http://www4.od.nih.gov/oba/rac/aboutrdagt.htm

Role of the Recombinant DNA Advisory Committee (RAC) and the Protocol Review Process
http://www.med.cornell.edu/research/downloads/talk1.ppt

Institutional Biosafety Committee (IBC) webpage
http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm

Requirement for Institutional Biosafety Committee (IBC) in the NIH Guidelineshttp://www.med.cornell.edu/research/downloads/talk3.ppt

Policies and Regulations regarding Laboratory Animal Welfare
http://grants.nih.gov/grants/olaw/olaw.htm
http://grants1.nih.gov/grants/olaw/references/phspol.htm
http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

Information Resources for Institutional Animal Care and Use Committee (IACUC)
http://www.iacuc.org/
http://grants.nih.gov/grants/olaw/GuideBook.pdf
http://grants.nih.gov/grants/olaw/Guide_addendum.pdf
http://www.nal.usda.gov/awic/pubs/IACUC/pubhlt.htm