Clinical trials inspections
- New FDA guidelines on clinical trials in women. // Patient Care;11/15/1993, Vol. 27 Issue 18, p21
Reports on the United States Food and Drug Administration's guidelines on clinical trials in women. Drug development tests; Effects of concurrent medications on women; Drug applications.
- A registry for clinical trials. Chollar, Susan // Annals of Internal Medicine;04/15/98, Vol. 128 Issue 8, p701
Presents information on the legalization of the United States Food and Drug Administration (FDA) Modernization Act of 1997 pertaining to a clinical trial registry. Information on the Public Law 105-115, Item 17: (82), Section 113; Forecast of the registry; Operation under the auspices of the...
- FDA cites Johns Hopkins in asthma death. // Medical Marketing & Media;Aug2001, Vol. 36 Issue 8, p32
Reports on the release of inspectional observations by the U.S. Food and Drug Administration for the Johns Hopkins Astham & Allergy Clinic in Baltimore, Maryland. Controversy over death following inhalation of hexamethonium; Failure of clinical investigator to submit required applications and...
- FDA needs to better manage gender trail data. // Medical Marketing & Media;Sep2001, Vol. 36 Issue 9, p34
Reports on the need for the Food and Drug Administration to strengthen surveillance of gender differences in clinical trial data in the U.S. Evidence on gender bias in clinical trials; Citation of the agency recommending the policy.
- Market Pulse. // Pharmaceutical Executive;Feb2005, Vol. 25 Issue 2, p23
Presents a graph depicting the number of clinical trials approved by the U.S. Food and Drug Administration.
- Rule Amends Consent Procedures. // Health Data Management;Feb2011, Vol. 19 Issue 2, p36
The article reports that the U.S. Food and Drug Administration has published a final rule that would require patients in clinical trials to be informed that trial information will be entered into a national database, thus amending the Food and Drug Administration Amendments Act of 2007.
- Draft Guidance Supports Remote Monitoring. // BioWorld Today;9/6/2011, Vol. 22 Issue 172, p4
The article reports on a draft guidance document issued by the U.S. Food and Drug Administration (FDA) aimed at helping clinical trial sponsors keep up with technology.
- Clinical trial evidence supporting FDA approvals varies widely. // Infectious Disease News;Feb2014, Vol. 27 Issue 2, p33
The article discusses the variation in the quality and scope of clinical trial evidence used by the U.S. Food and Drug Administration (FDA) as grounds for drug approvals, according to a study by N.S. Downing and colleagues published in the "Journal of American Medical Association" as of February...
- Prevention of Dichloroacetate Toxicity. // Exceptional Parent;Feb2003, Vol. 33 Issue 2, p42
Presents a clinical trial for the drug Nitisione, Orfadinin TM (NTBCp conducted by the General Research Center in Florida. Ability to reduce dichloroacetate toxicity; Baseline test of NTBC; Assistance given by the National Institutes of Health and the Food and Drug Administration.
- OBSERVATIONS. Formanek Jr., Raymond // FDA Consumer;Mar/Apr2007, Vol. 41 Issue 2, p2
The article discusses various reports published within the issue, including one on the U.S. Food and Drud Administration works to keep the farm produce in the country safe for consumers and another on the advances in clinical trials.