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The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases. The aim of the programme is to expedite the development, assessment and review of medical devices in order to provide timely access to patients and healthcareproviders.
In recent years, we’ve seen an increase in awareness among healthcareproviders and better diagnosis of rare diseases, leading to improved access to care for patients with these uncommon conditions. 4; 4/20/2020; DOI:10.7759/cureus.7745 ” Molecular Vision; 12/28/2020; p789 [5] Sahel J et al. ” Cureus; V.12;
Real-World Evidence (RWE) Real-word data from electronic health records, insurance claims, wearables, social media, and other sources can provide important insights into real-life drug performance, patient adherence, and market trends to inform better decision-making.
For sales representatives, the PRC and CSPP certifications can enhance this understanding and communication with HCPs: Pharmaceutical Representative Certification (PRC) : This certification provides professionals with a foundational knowledge of pharmacology, regulatory standards, and effective communication strategies. link] Rang, H.
Case Summary: In 2020, this company agreed to pay $678 million to settle allegations that it violated the False Claims Act by paying kickbacks to doctors. The Department of Justice (DOJ) accused this company of providing lavish meals, entertainment, and speaker fees to healthcareproviders (HCPs) to induce them to prescribe their drugs.
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