Gaps in the evaluation and monitoring of new pharmaceuticals: proposal for a different approach
- NHS data on statin outcomes. Black, Stephen // BMJ: British Medical Journal;8/22/2015, Vol. 351 Issue 8022, ph4305
A letter to the editor is presented in response to the article "Statins for People at Low Risk" by E. Parish, T. Bloom and F. Godlee in the July 21, 2015 issue.
- US proposal to expand access to untested drugs draws fire. Waltz, Emily // Nature Medicine;Feb2007, Vol. 13 Issue 2, p111
The article focuses on the United States Food and Drug Administration's proposal to allow access of experimental drugs to people. Experts say that the proposal will create confusion in drug development and expose people to unsafe drugs. The article states that the proposal is opposed because, it...
- FDA finalizes rules on accessing experimental drugs. Traynor, Kate // American Journal of Health-System Pharmacy;9/15/2009, Vol. 66 Issue 18, p1596
The article reports on the final rule titled "Expanded Access to Investigational Drugs for Treatment Use" released by the U.S. Food and Drug Administration (FDA) in August 2009. It states that the final rule outlines the policies which ensure that patients have access to investigational drugs...
- Rosiglitazone and implications for pharmacovigilance. Kazi, Dhruv // BMJ: British Medical Journal (International Edition);6/16/2007, Vol. 334 Issue 7606, p1233
This editorial examines the use of rosiglitazone or Avandia in the treatment of diabetes and the studies that suggest its use is associated with an increased risk of heart failure. The author states that postmarketing drug surveillance, or pharmacovigilance, is the weakest link of the drug...
- JANUARY UPDATES. // Monthly Prescribing Reference;Jan2011, Vol. 27 Issue 1, pA.13
The article presents clinical charts and a list of drug monographs that have been updated in January 2011 issue of "Monthly Prescribing Reference," which include Concerta, Insulin Administration, and Insulin Pen Devices, along with various drugs which were being investigated for its therapeutic...
- Off-Label Promotion, On-Target Sales. Fugh-Berman, Adriane; Melnick, Douglas // PLoS Medicine;Oct2008, Vol. 5 Issue 10, p1432
The article focuses on off-label use of drugs in the U.S. It is the practice by prescribing pharmaceuticals for a purpose outside the scope of a drug's approved label. It is stated that off-label use has not been subjected to test and review that are preconditions for marketing approval....
- Drug Trials and Older People. Witham, Miles D. // Drugs & Aging;2011, Vol. 28 Issue 8, p679
No abstract available.
- From the Editor's desk. Tyrer, Peter // British Journal of Psychiatry;Mar2010, Vol. 196 Issue 3, p254
An introduction to the journal is presented in which the editor discusses reports published within the issue including the importance of attention to methodology in clinical trials, restriction of publication bias to drug trials, and the mental ill-effects of neglect, abuse, and deprivation.
- National Pharmaceutical Institute answers allegations. // Life Science Today;Feb2001, Vol. 2 Issue 1, p7
Reports on the Hungarian National Pharmaceutical Institute's denial that dangerous drug experiments are being carried out on unsuspecting patients. Rules concerning clinical trials in Hungary; Reasons that make Europe an easier place to find clinical trial patients.
- ADVANCE-2: Apixaban had favorable risk-benefit profile compared with enoxaparin. // Hem/Onc Today;8/10/2009, Vol. 10 Issue 15, p23
The article discusses the results of a clinical drug trial which revealed the therapeutic use of apixaban for thromboprophylaxis after total knee replacement.