The future of drug safety

Clinical Pharmacology and Therapeutics

Volumn 81, Issue 2, 2007, Pages 161-163

  Breckenridge, A ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NATALIZUMAB;

DRUG APPROVAL; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE DELIVERY; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REVIEW; RISK BENEFIT ANALYSIS; UNITED KINGDOM; UNITED STATES;

DRUG EVALUATION; DRUG TOXICITY; EUROPE; FORECASTING; HUMANS; INSTITUTE OF MEDICINE (U.S.); INTERNATIONAL COOPERATION; ORGANIZATIONAL OBJECTIVES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33846567975     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100079     Document Type: Review

References (7)

1. Institute of Medicine of the National Academies. About the National Academies and the IOM Study Process 〈http://www.iom.edu/?id=33953〉 (2006).
2. World Health Organization. CIOMS Working Group VI. Management of Safety Information from Clinical Trials. 〈http://www.cioms.ch/ management_of_safety_information. htm〉(2005).
3. International Conference on Harmonisation Steering Committee. Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting 〈http://www.nihs.go.jp/dig/ich/efficacy/e2d/e2d_031112_e. pdf〉 (2003).
4. US Food and Drug Administration. Natalizumab (marketed as Tysabri) Information 〈http://www.fda.gov/cder/drug/infopage/natalizumab/〉 (2006).
5. US Food and Drug Administration. Title 21 Food and Drugs, Part 201-Labeling 〈http://www. access.gpo.gov/nara/cfr/waisidx_98/21cfr201_ 98.html〉 (1998).
6. European Commission. Stichting AESGP Foundation. Development of an information policy for medicinal products 〈http://www.aesgp.be/ ResearchProject/FinalReport.pdf〉 (2002).
7. Safety information: Healthcare professional reporting, Black Triangle Scheme 〈http://www. mhra.gov.uk/home/idcplg?IdcService=SS_ GET_PAGE&nodeId=748〉 (2006).