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Conference on institutional biosafety committees. (Regulatory Update).
January 01, 2003
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FDA approved Prozac for pediatric use to treat depression and OCD. (Re...
January 01, 2003
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FDA establishes Office of Combination Products. (Regulatory Update).
January 01, 2003
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User fees strike medical devices. (Regulatory Update).
January 01, 2003
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New Privacy Board established to address HIPAA `waiver of consent'. (R...
January 01, 2003
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FDA warning letters. (Regulatory Update).(compliance requirements in c...
November 01, 2002
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FDA issues guidance development plans. (Regulatory Update).(Brief Arti...
November 01, 2002
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OHRP/FDA collaborate on smallpox vaccine clinical trials in children. ...
November 01, 2002
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Bridging the clinical trial recruitment leap. (Issues In Clinical Tria...
November 01, 2002
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Continuing education.
November 01, 2002
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A HIPAA primer for research practitioners.(Health Insurance Portabilit...
November 01, 2002
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Stem cell research and cloning: the state of the science.
November 01, 2002
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OHRP director resigns, plans to return to Harvard. (In the News).(Greg...
November 01, 2002
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Judge strikes down pediatric rule. (In the News).
November 01, 2002
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From the editors.(human medical experimentation)(Editorial)
November 01, 2002
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A rose by any other name? (Regulatory Update).(Secretary's Advisory Co...
November 01, 2002
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Waiver of certain human subject protections for research on prisoners....
November 01, 2002
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FDA warning letters. (Regulatory Update).
September 01, 2002
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Draft guidance on clinical holds and investigator misconduct. (Regulat...
September 01, 2002
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PHS Policy on animal use changes. (Regulatory Update).(Public Health S...
September 01, 2002
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Gene therapy patient tracking system. (Regulatory Update).(Brief Artic...
September 01, 2002
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Can regulation by polling be far behind? (Regulatory Update).(Brief Ar...
September 01, 2002
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FDA plans to consolidate drug reviews. (Regulatory Update).
September 01, 2002
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Correction.('New human subject protection legislation debuts,' in the ...
September 01, 2002
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Ethical: OHRP guidance on continuing review and written IRB procedures...
September 01, 2002
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Exam for continuing education: research practitioner 3.5.
September 01, 2002
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Continuing education.
September 01, 2002
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Visual design in the informed consent process. (Issues In Research Man...
September 01, 2002
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Challenges in the informed consent process: identifying design strateg...
September 01, 2002
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A systems approach to protecting research participants: the Institute ...
September 01, 2002
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From the editors.(human experimentation in medicine)
September 01, 2002
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FDA guidance on IND exemptions. (Regulatory Update).(investigational n...
July 01, 2002
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Recent FDA warning letters. (Regulatory Update).(Brief Article)
July 01, 2002
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NIH guidelines on recombinant DNA research updated. (Regulatory Update...
July 01, 2002
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Bioterrorism initiatives at FDA. (Regulatory Update).(Brief Article)
July 01, 2002
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OHRP launches IRB quality improvement program. (Regulatory Update).(Of...
July 01, 2002
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Legal: new human subject protection legislation debuts. (Current Consi...
July 01, 2002
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Regulatory: de-identified information--standards for privacy of indivi...
July 01, 2002
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Pitfalls of IRB review of post-marketing protocols.(Institutional Revi...
July 01, 2002
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Post-marketing research/Phase 4 studies: informed consent for surveill...
July 01, 2002
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Small Business Innovation Research: seed investments for technology en...
July 01, 2002
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From the editors.(Brief Article)(Editorial)
July 01, 2002
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Post-IRB-approval monitoring of clinical trials: assessment of investi...
May 01, 2002
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The National Cancer Institute and its role as a sponsor of cancer rese...
May 01, 2002
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Qualifying an IRB: a guide for making compliance assessments. (Issues ...
May 01, 2002
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NCQA announces expansion of VA human subjects accreditation program. (...
May 01, 2002
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Regulatory: clinical trials data bank. (Current Considerations).
May 01, 2002
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FDA pediatric rule revision. (Regulatory Update).(Brief Article)
May 01, 2002
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Updated OHRP guidance on stem cells. (Regulatory Update).(Office for H...
May 01, 2002
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21 CFR part 11 and draft guidance on time stamps. (Regulatory Update)....
May 01, 2002
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Hearings on human subject protection. (Regulatory Update).(Brief Artic...
May 01, 2002
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Sponsor-investigator Warning Letter from FDA. (Regulatory Update).(Ali...
May 01, 2002
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IRB Warning Letter from FDA. (Regulatory Update).(Ochsner Clinical Fou...
May 01, 2002
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From the editors.
May 01, 2002
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Human subject protections: ethical issues in overseas medical research...
March 01, 2002
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Clinical trials newsletters: just fluff or a critical trial management...
March 01, 2002
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Regulatory: considerations for international research. (Current Consid...
March 01, 2002
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New reporting regulations being considered. (Regulatory Update).(Brief...
March 01, 2002
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Excerpts from FDA warning letters. (Regulatory Update).(Excerpt)(Brief...
March 01, 2002
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From the editors.
March 01, 2002
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Ethical oversight of research in developing countries: The National Bi...
March 01, 2002
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Conflicts of interest in institutional-based IRBs versus independent I...
January 01, 2002
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Regulatory: orphan drug regulation. (Current Considerations).
January 01, 2002
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Ethical: focus on data monitoring committee SOPs. (Current Considerati...
January 01, 2002
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Update on 45 CFR 46 subpart B. (Regulatory Update).("Additional Protec...
January 01, 2002
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OHRP guidance on stem cells. (Regulatory Update).(Office for Human Res...
January 01, 2002
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HHS seeks comments on reducing regulatory burdens. (Regulatory Update)...
January 01, 2002
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Excerpts from FDA warning letters. (Regulatory Update).
January 01, 2002
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GAO report on conflict of interest. (Regulatory Update).(General Accou...
January 01, 2002
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Notable FDA approvals. (Regulatory Update).(Xigris from Eli Lilly and ...
January 01, 2002
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Correction.(Correction Notice)
January 01, 2002
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From the editors.
January 01, 2002
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The persistence of biological aggression: a history of bioterrorism an...
January 01, 2002
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The challenge of clinical investigation of agents used in bioterrorism...
January 01, 2002
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Exam for Continuing Education: Research Practitioner 2:6.(continuing m...
November 01, 2001
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