general questions about FDA good clinical practice regulations and policy general questions about the FDA clinical Bioresearch Monitoring Program, and specifically clinical investigator, Institutional Review Board (IRB), sponsor, monitor, and contract research organization programs questions about or suggestions relating to FDA's Information Sheets for IRB's and Clinical Investigators

Call 301-827-0425 (fax: 301-827-0482) (Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs) for:

questions about the overall FDA Bioresearch Monitoring Program, and specifically the Good Laboratory Practice (GLP; nonclinical laboratories) Program

general Bioresearch Monitoring Program enforcement issues reports made pursuant to 21 CFR 56.108(b) and 56.113 involving an FDA-regulated product if you do not know which FDA Center has jurisdiction (e.g., drug, medical device, biological product) including: unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)] serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108(b)(2)] suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]

PRODUCT SPECIFIC DRUG PRODUCTS--Center for Drug Evaluation and Research (CDER)

Call 301-827-4573 (Drug Information Branch, CDER) for questions about:

the legal status of a test article (e.g., whether an article is a "drug," or whether a drug is approved for marketing) whether research with a marketed drug in a particular study "significantly increases the risks" (or decreases the acceptability of the risks) and therefore requires an IND whether an investigational new drug application (IND) is required for a drug study Call 301-594-0020; fax: 301-594-1204 (Division of Scientific Investigations, Office of Medical Policy, CDER) for questions about:

human subject protection regulations pertaining to drugs [21 CFR Parts 50, 56, 312 and 361]

CDER-assigned IRB Inspections (e.g., "FDA-483s" and "Warning Letters") reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a drug product including:

unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)] serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108(b)(2)] suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]

reporting complaints related to human subject protection/Good Clinical Practice in FDA-regulated drug trials Call 301-594-1032; fax: 301-827-5290 (Good Clinical Practice Branch, Office of Medical Policy, CDER) for questions about:

regulations pertaining to clinical investigators [21 CFR Part 312] CDER-assigned Clinical Investigator Inspections (e.g., "FDA-483s" and "Warning Letters") CDER's new document e-mail list--Subscribe to receive daily or weekly notification about new material on CDER's Website.

BIOLOGICAL PRODUCTS--Center for Biologics Evaluation and Research (CBER)

Call 301-827-6221; fax: 301-827-6748 ( Bioresearch Monitoring Branch, Office of Compliance and Biologics Quality, CBER) for questions about:

the legal status of a test article (that is, whether an article is a biological drug or device, or whether an IND or IDE [investigational device exemption] is required for an investigational study) human subject protection regulations pertaining to biologics, including certain devices or in vitro diagnostics regulated by CBER [21 CFR Parts 50, 56, 312, 812]

CBER-assigned IRB Inspections (e.g., "FDA-483s" and "Warning Letters") CBER-assigned Clinical Investigator Inspections (e.g., "FDA-483s" and "Warning Letters")

reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a biologic product including:

Questions about specific products or classes of products should be directed to one of the following offices: Office of Therapeutics Research and Review (301-827-5101) Office of Vaccines Research and Review (301-827-3070) Office of Blood Research and Review (301-827-3518) Call 301-827-2000; fax: 301-827-3843 (Division of Communication and Consumer Affairs, CBER) for reporting complaints related to human subject protection/Good Clinical Practice in FDA-regulated biologics trials CBER list to receive all fractionated product recall and blood information documents, as well as all other new documents, including guidelines, points to consider, and other CBER information. To subscribe, send an e-mail message to: cberinfo@listmanager.fda.gov with the word "subscribe" as the first word of the subject or the first word of the first line of the message.

MEDICAL DEVICES--Center for Devices and Radiological Health (CDRH)

Call 800-638-2041 (Division of Small Manufacturers Assistance, CDRH) for copies of publications pertaining to device studies.

Call 301-594-1190; fax: 301-594-2977 (Program Operation Staff, CDRH) for questions about:

whether an investigational device exemption (IDE) is required for a device study

whether a device is deemed "significant risk" or "non-significant risk" unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)] suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]

Call 888-463-6332 or 800-638-2041; fax: 301-443-9535 (Consumer Staff, Division of Small Manufacturers Assistance, CDRH) for questions about:

whether a device is approved for marketing Call 301-594-4718; fax: 301-827-6748 (Division of Bioresearch Monitoring, Office of Compliance, CDRH) for questions about:

human subject protection regulations pertaining to devices [21 CFR Parts 50, 56, and 812]

informed consent, standard operating procedures, records, and reports. serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations involving a medical device [21 CFR 56.108(b)(2)]

reporting complaints related to human subject protection/Good Clinical Practice in FDA-regulated medical device trials "Device Advice" is CDRH's self-service site for medical device and radiation emitting product information.

"Bioresearch Monitoring Advice" provides information about FDA's bioresearch monitoring program.

OTHER

Call 301-402-5552; fax 301-402-2071 [Office for Human Research Protections (OHRP) Education Program] for general information about the Department of Health and Human Services human subject regulations at 45 CFR 46.

Call 301-496-7005; fax 301-402-0527 [Office for Human Research Protections (OHRP) Assurance Program] for information about the OHRP Assurances Program.

Call 301-402-5567; fax 301-402-2071 [Office for Human Research Protections (OHRP) Compliance Oversight Program] for information about noncompliance with HHS regulations.

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