Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels
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DOI: 10.1002/cpt.2602
Abstract: This review presents a European Federation of Pharmaceutical Industries and Association/PreClinical Development Expert Group (EFPIA‐PDEG) topic group consensus on a data‐driven approach to harmonized contraception recommendations for clinical trial protocols and product labeling. There is… read more here.
Keywords: clinical trials; contraception; product labeling; contraception recommendations ... See more keywords
Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)
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DOI: 10.1016/j.vaccine.2020.09.067
Abstract: With the ongoing globalization of the pharmaceutical industry, efforts to harmonize technical requirements of registering drugs and biologics, including vaccines, have produced a number of useful guidelines utilized around the world. However, such efforts have… read more here.
Keywords: information; dissonance examining; product labeling; product ... See more keywords