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… per the Acts): The right to access: You have the right to request copies of your personal data. We may charge you a … service. The right to rectification: You have the right to request that we correct any information you believe is inaccurate. You also have the right to request us to complete the information you believe is …
PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information Exchange (PIE) Materials Unapproved Medical Product Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved use dossier, allows you to communicate key product …
… database studies for pharmaceutical clients at the request of the US FDA, EMA, and other national agencies in … Medicare and Medicaid administrative claims National Death Index (NDI) National Center for Health Statistics surveys …
… to Work for Disability Inclusion by Disability Equality Index® Share on: July 21, 2022 Top-scorers demonstrated … Inclusion by scoring 100 in the Disability Equality Index® (DEI), the world’s most comprehensive benchmarking … to have earned a top score on the Disability Equality Index and be a 2022 Best Place to Work for Disability …
Drug Safety in Pregnancy Satisfy Regulatory Requirements With Help From Our Perinatal Pharmacoepidemiology Research Team The safety of medical products when used in pregnancy is often not well characterized at the time of marketing authorization unless …
… Assessment at RTI Health Solutions. Transcript A frequent request we receive from clients relates to labeling, and we …
Submission Requirements of Nordic HTA Organizations for Medical Technologies Maria Kinderås, MSc Senior Associate, Market Access and Outcomes Strategy Transcript: While health technology assessments, or HTAs, of pharmaceutical products have existed for a …
… device has been approved or received clearance, payers can request a wide range of information from manufacturers. They …
Pooled Data Analysis of Long-Term Treatment Effect OPPORTUNITY Our client had a treatment for kidney disease that had been shown to slow kidney function decline in various short-term clinical studies. They wanted to assess their treatment compared with …
… the right to access and review the photos taken of you and request their removal if you are not satisfied with their …