| National Cancer Institute |
This gives a complete information on cancer research and the undergoing clinical trials in the field of oncology. http://www.cancer.gov/clinicaltrials/learning
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| Studies at NIH |
This site allows you to search the collection of research studies being conducted at the NIH Clinical Center. http://clinicalstudies.info.nih.gov/index.html
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| Health Insurance Portability and Accountability Act |
Here you will find a brief overview of the federal legislation known as HIPAA. http://www.hopkinsmedicine.org/hipaa/
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| CenterWatch – Clinical Trial Listing Service |
This website provides information services used by patients, pharmaceutical, biotechnology and medical device companies, CROs and research centers involved in clinical research around the world. http://www.centerwatch.com/
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| Code of Federal Regulations – CFR |
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published by the US Government. CFR Title 21 deals with the regulations for Food and Drug Administration. http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
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| Current Controlled Trials |
This site allows users to search, register and share information about randomised controlled trials. Access to all the information on this site is free. http://controlled-trials.com/
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| U S Food and Drug Administration |
The USFDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics and products that emit radiation in USA. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. http://www.fda.gov/
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| Regulatory Affairs Professionals Society |
This site gets you a peek into the work involved in regulatory affairs in the field of health care. http://www.raps.org/personifyebusiness/
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| The Society for Clinical Trials |
This site provides you with the information on design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies. http://sctweb.org/
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| Medline plus |
This website will direct you to information to help answer health questions. It gives easy access to medical journal articles. It also has extensive information about drugs, an illustrated medical encyclopedia, interactive patient tutorials, and latest health news. http://www.nlm.nih.gov/medlineplus/clinicaltrials.html
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| Clinical Trials.Gov |
This is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals. http://clinicaltrials.gov/
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| National Institute of Health |
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Sciences, is the primary Federal agency for conducting and supporting medical research. http://www.nih.gov/
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| NIH and clinical research |
This site gives you answers to the FAQs related to clinical research, especially the questions related to subject participation in clinical trials.http://clinicalresearch.nih.gov/
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| National Human Genome Research Institute |
This site gives you a online resource of clinical research and trials. http://www.genome.gov/11510378
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| Biosearch Monitoring Information System File |
This website contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs. http://www.fda.gov/cder/foi/special/bmis/index.htm
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| CDER Guidance Documents |
This website contains guidance documents released by the FDA for efficient running of a clinical trial. Guidance documents represent the Agency's current thinking on a particular subject. http://www.fda.gov/cder/guidance/index.htm
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| CDRH Bioresearch Monitoring |
This website gives you the guidelines to ensure the quality and integrity of data and information submitted in support of investigational and marketing clearance applications or submissions and to ensure that human subjects taking part in investigations are protected from undue hazard or risk. http://www.fda.gov/cdrh/comp/bimo.html
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| CDRH Device Advice |
This website gives you information on medical devices other radiation emitting products and the procedure to obtain regulatory information concerning medical devices. http://www.fda.gov/cdrh/devadvice
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| CDRH Guidance |
This website gives you information regarding the guidance pertaining to FDA modernization act. http://www.fda.gov/cdrh/modact/modguid.html
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| Center for Biologics Evaluation and Research (CBER) |
This website gives you details regarding the new drugs, mainly vaccines. http://www.fda.gov/cber
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| Computerized Systems used in Clinical Trials |
This website gives details of office of regulatory affairs of USFDA and also provides guidance to the industry. http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
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| Drug Approvals List |
This website provides the list of drugs approved by the FDA. http://www.fda.gov/cder/da/da.htm
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| Electronic Regulatory Submission & Review |
This website provides information about the electronic submission of regulatory information to the CDER. Additional guidance documents, when available in draft or final form, will be added to this page. http://www.fda.gov/cder/regulatory/ersr
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| Federal Food, Drug & Cosmetic Act |
This website contains the details of federal food, drug and cosmetic act. http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
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| FDA Modernization Act of 1997 |
The complete details of the FDA Modernization act of 2007 is given in this web site. http://www.fda.gov/CDER/guidance/105-115.htm
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| Good Clinical Practice |
This website tells about the good clinical practice in FDA regulated clinical trials. http://www.fda.gov/oc/gcp
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| Information for Health Professionals |
This website gives information for health professionals involved in clinical trials. http://www.fda.gov/healthprofessionals/
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| Laws Enforced by FDA |
This website contains the laws enforced by the FDA and related statutes. http://www.fda.gov/opacom/laws/
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| MedWatch |
This website gives you information on drugs and other medical products regulated by the U.S. Food and Drug Administration. http://www.fda.gov/medwatch
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| National Drug Code (NDC) Directory |
This website contains the current list of all drugs manufactured, prepared, propagated, compounded or processed by the FDA for commercial distribution. http://www.fda.gov/cder/ndc
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| New Drug Approval Packages |
This website gives the new drug approval packages and the regulatory process involved. http://www.fda.gov/cder/ndc
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| Orange Book (Approved Drugs) |
This website gives a list of Food and Drug Administration Center for Drug Evaluation and Research approved drug products with therapeutic equivalence valuations. http://www.fda.gov/cder/orange/adp.htm
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| Press Releases & Talk Papers |
The website gives you a list of press releases from the FDA. http://www.fda.gov/opacom/hpnews.html
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| Warning Letters |
The website gives the warnings from FDA and also the responses. http://www.fda.gov/foi/warning.htm
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