Articles |
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Spotting duplicate reporting.(In the News)
March 01, 2008
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Device investigation warning letter shows unusual deficiencies.(Regula...
March 01, 2008
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OHRP Spanish pamphlet now available.(Regulatory Update)
March 01, 2008
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Exam for continuing education.
March 01, 2008
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New government docket and document access site announced.(Regulatory U...
March 01, 2008
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Public workshop on hemoglobin-based oxygen carriers.(Regulatory Update...
March 01, 2008
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Quality improvement: when is it research that requires informed consen...
March 01, 2008
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Patient autonomy and complex decision making.
March 01, 2008
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Competition challenges U.S. site profitability.(ISSUES IN RESEARCH MAN...
March 01, 2008
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FDA seeks advisory committee consumer representatives.(Regulatory Upda...
March 01, 2008
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FDA final guidance on bioresearch review and inspections of medical de...
March 01, 2008
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FDA draft guidance on distributing articles about unapproved drug/devi...
March 01, 2008
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FDA draft guidance on developing drugs for ABOM.(Regulatory Update)
March 01, 2008
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FDA/IDSA community-acquired pneumonia workshop transcript.(Regulatory ...
March 01, 2008
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FDA's clinical trials transformation initiative.(Regulatory Update)
March 01, 2008
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FDA issues several new final guidance documents.(Regulatory Update)
January 01, 2008
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Premarket clinical evaluation of drug-induced liver injury.(Regulatory...
January 01, 2008
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FDA advisory committee draft guidance documents issued.(Regulatory Upd...
January 01, 2008
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FDA issues several new treatment draft guidance documents.(Regulatory ...
January 01, 2008
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Improving the quality of clinical research: recognizing issues in trai...
January 01, 2008
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Informed consent in clinical trials: from process to paper.
January 01, 2008
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Regulatory and ethical issues in conducting gene therapy research.
January 01, 2008
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Medical professionalism.(In the News)
January 01, 2008
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The evolving declaration.(In the News)
January 01, 2008
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Comments on oversight of genetic testing sought.(Regulatory Update)
January 01, 2008
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Expanded protections for vaccine manufacturers.(Regulatory Update)
January 01, 2008
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FDA workshop on pandemic influenza vaccine development.(Regulatory Upd...
January 01, 2008
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FDA draft guidance for bioequivalence studies.(Regulatory Update)(Food...
January 01, 2008
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FDA draft guidance for IVD device studies.(Regulatory Update)(Food and...
January 01, 2008
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Changes requested to IRB expedited review list.(Regulatory Update)(ins...
January 01, 2008
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Payments to research subjects: ethical issues.(Exam for Continuing Edu...
November 01, 2007
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FDA pilot program for electronic preclinical data submissions.(Regulat...
November 01, 2007
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FDA workshop on cellular/tissue scaffolding.(Regulatory Update)
November 01, 2007
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NIH policy and database on genome-wide association studies announced.(...
November 01, 2007
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FDA creates docket to receive pandemic flu vaccine information.(Regula...
November 01, 2007
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FDA issues companion to pharmacogenomic data guidance.(Regulatory Upda...
November 01, 2007
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Final guidance on toxicity grading.(Regulatory Update)
November 01, 2007
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OHRP seeks comments on decisionally impaired adults in research.(Regul...
November 01, 2007
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Describing the role of the clinical research nurse.(Survey)
November 01, 2007
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Pharmacogenomics and the evolving regulatory paradigm.
November 01, 2007
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Payments to research subjects: ethical issues.
November 01, 2007
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Medical school relationships with industry.(In the News)
November 01, 2007
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NIH proposed rule to permit multiple principal investigators.
July 01, 2007
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How to critically review and appraise published clinical literature.
July 01, 2007
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FDA solicits members for new risk communication advisory committee.
July 01, 2007
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New regulations for dietary supplements.(In the News)
July 01, 2007
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The Supreme Court and medical devices.(In the News)
July 01, 2007
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Ball of confusion: how stem cells have stymied review boards.
July 01, 2007
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Supervisory responsibilities of investigators.
July 01, 2007
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FDA releases final guidance on computerized systems used in clinical t...
July 01, 2007
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FDA releases final guidance on pandemic influenza vaccine.(Regulatory ...
July 01, 2007
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FDA releases final guidance on seasonal inactivated influenza vaccine....
July 01, 2007
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FDA releases final guidance on clinical trial endpoints for cancer dru...
July 01, 2007
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FDA draft guidance on developing drugs and biologics for malaria.(Regu...
July 01, 2007
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FDA public workshop on anthrax vaccines.(Regulatory Update)
July 01, 2007
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Sponsor-investigator FDA warning letter.(Regulatory Update)
July 01, 2007
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Perspectives on informed consent in developing countries.(In the News)
May 01, 2007
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'Natural' remedies and clinical trials.(In the News)
May 01, 2007
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Ethical issues with health care research in developing countries.
May 01, 2007
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Caregiver vs. scientist: the sometimes conflicting roles between the d...
May 01, 2007
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FDA solicits nominations for members on advisory committees.(Regulator...
May 01, 2007
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FDA proposes e-CRF in XML pilot project.(Regulatory Update)
May 01, 2007
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FDA releases final guidance on studies of steroids in children.(Regula...
May 01, 2007
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FDA and NCI memoranda of understanding.(Regulatory Update)
May 01, 2007
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FDA issues draft guidance on advisory committee member conflicts.(Regu...
May 01, 2007
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Priority list of drugs for pediatric research.(Regulatory Update)
May 01, 2007
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Changing investigator meeting formats.(ISSUES IN RESEARCH MANAGEMENT)
May 01, 2007
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FDA releases final guidance on statistics and IVD study results.(Regul...
May 01, 2007
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RAC guidance on lentiviral vectors.(Recombinant DNA Advisory Committee...
May 01, 2007
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SACGHS requests comments on draft pharmacogenomics report.(Secretary's...
May 01, 2007
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FDA issues draft guidance on adverse event reporting.(Regulatory Updat...
May 01, 2007
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Physicians and drug companies.(In the News)
May 01, 2007
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FDA proposes e-CRF in XML pilot project.(Regulatory Update)
May 01, 2007
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Publication ethics.(In the News)
March 01, 2007
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Issues in clinical research manager education and training.
March 01, 2007
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