Analysis: First Year of the New Early Access Authorization in France

Objectives: To review and analyze the new early access authorization program in France launched in July 2021. Method(s): Treatments that were processed under the early access authorization program between July 2021 and June 2022 were analyzed. The assessments were examined for therapy area, processing timeline, and data used in the evaluation. Result(s): As of 30 June 2022, 55 of the 66 decisions (83%) that have been published by HAS were granted early access, and 11 (17%) applications were refused. Among those granted early access, 37 (67%) already had a marketing authorization (MA), of which 25 (68%) had conditional MA and 11 (30%) were granted orphan status;18 (33%) applied to the program before obtaining regulatory approval (pre-MA). Among the treatments granted early access after MA, one received ASMR II, 15 received ASMR III, 2 Received ASMR IV, 5 received ASMR V rating, and 13 had not been evaluated for the indication. The average time taken for the processing of all applications (receipt of complete file to date of adoption) was 65 days (range, 1-121);mean time for ANSM opinion on the product's presumed efficacy and safety in the absence of MA was 55 days (range, 4-112). Oncology drugs accounted for 21 (39%) of applications. Most decisions were based on phase 2-3 clinical data for technologies with or without MA. Only two positive, pre-MA early access authorization requests used phase 1 clinical data for treatments indicated in pre-exposure prophylaxis of coronavirus 2019 and unresectable or metastatic triple-negative breast cancer. Contributions from stakeholders, including patient and user groups, were involved in 39 (59%) applications (both pre-MA and post-MA). Conclusion(s): Overall, the time taken to evaluate the early access applications is significantly lower compared with the 3-month examination period stipulated by the program, facilitating a quick access to patients with high unmet need. Copyright © 2022

FUNGAL INFECTIONS ASSOCIATED WITH COVID-19 – DENTISTS’ PERSPECTIVE

Aim: To assess the association between COVID-19 and oral fungal infections. Methods: A review of fungal infections associated with COVID-19 was done by using major databases like PubMed, Scopus, Clinical Key, and EBSCO. Results: It is evident from these published studies that, in addition to systemic complications, COVID-19 also compromises oral health. This review brings an insight into the possibility of fungal infections co-existing with COVID-19. Clinical Significance: It is important to assess the risk factors in order to manage fungal infections in patients who have a positive history of COVID-19. © 2022 Nova Science Publishers, Inc.

Online learning during COVID-19 pandemic -Medical students' perception

Introduction and Aim: A sudden shift of medical education from physical class teaching to online teaching during the COVID-19 pandemic created concern in both the students and teachers. The aim of the study is to evaluate the perception of medical students towards online learning during COVID-19 pandemic lockdown. Material(s) and Method(s): This observational study included all the MBBS students of our institution. The study was conducted after obtaining ethical clearance from the Institutional Ethics Committee. A validated questionnaire was used to collect the information. The data was analysed using the statistical software SPSS-28. Demographic variables were expressed in terms of frequencies and percentages. Data was analysed using Chi square test and Mann Whitney U test. P-value of less than 0.05 was considered statistically significant. Result(s): Five hundred sixty-five students of both genders out of total 600 (94%) participated. 54.3% experienced online classes for the first time and 48.1% studied online for 3-6 hrs. They liked recorded MP4 videos of their own teachers. Majority felt that online classes should be more interactive. They did not want the online classes to continue after the pandemic and opined that online classes cannot replace classroom teaching. Majority agreed that online learning saved time of travel, saves cost, was flexible but practical knowledge and interaction with teachers and patients was lacking. They experienced additional stress and their examination results are affected. Conclusion(s): Online learning is a less effective mode for learning practical skills and may be used as a supplementary mode to teach a few elective topics. Copyright © 2022, Indian Association of Biomedical Scientists. All rights reserved.