Safety and efficacy of drugs in pregnancy

Journal of Population Therapeutics and Clinical Pharmacology

Volumn 18, Issue 3, 2011, Pages

  Knoppert, David ^a,b  

^a LONDON HEALTH SCIENCES CENTRE   (Canada)

^b UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

Advocacy; Lactation; Pharmacokinetics; Pregmedic; Pregnancy; Registries; Women

Indexed keywords

CANADA; DRUG EFFICACY; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; HUMAN; LACTATION; NON PROFIT ORGANIZATION; PREGNANCY; PREGNANT WOMAN; REGISTER; REVIEW; ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; FEMALE; FOOD AND DRUG ADMINISTRATION; MALE; METHODOLOGY; PRACTICE GUIDELINE; PREGNANCY COMPLICATION; SEX DIFFERENCE; UNITED STATES;

DRUG; GENERIC DRUG;

CANADA; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG LABELING; DRUGS, GENERIC; FEMALE; GUIDELINES AS TOPIC; HUMANS; LACTATION; MALE; PHARMACEUTICAL PREPARATIONS; PREGNANCY; PREGNANCY COMPLICATIONS; REGISTRIES; SEX FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84860588574     PISSN: 17106222     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Adapted from: FDA Consumer magazine. Volume 35, Number 3, May-June 2001. http://www.perinatology.com/Archive/FDA%2 0CAT.htm (June 28, 2011).
2. U.S. Food and Drug Administration. News & Events. FDA News Release: FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding. (May 28, 2008) http://www.fda.gov/NewsEvents/Newsroom/Pr essAnnouncements/2008/ucm116902.htm (July 15, 2011).
3. U.S. Food and Drug Administration. News & Events. FDA News Release: FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy. New collaborative research program to study effects on mothers and their babies. (December 30, 2009) http://www.fda.gov/NewsEvents/Newsroom/Pr essAnnouncements/ucm195934.htm (July 15, 2011).
4. European Medicines Agency. Guideline on the Exposure to Medicinal Products. www.ema.europa.eu/./en_GB/document_librar y/Regulatory_and_procedural_guideline/2009/1 1/WC500011303.pdf (June 28, 2011).
5. European Medicines Agency. Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling. 2008 July 24. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId= WC500003307 (June 28, 2011).
6. Canadian Institutes of Health Research. About DSEN. In brief: The Drug Safety and Effectiveness Network (DSEN). Background. 2009 September 29. http://www.cihrirsc. gc.ca/e/39389.html (June 28, 2011).