First Coronavirus Treatment Approved by FDA
FDA has approved the first COVID-19 treatment. Gilead Science’s Remdesivir has been approved for use in adult and pediatric patients (12+ and weighing at least 88 pounds) for the treatment of COVID-19 requiring hospitalization. Since the approval does not cover all patient populations that the previous EUA covered, the EUA has been revised to cover those patients.
MHRA has Published Several Guidance Documents to Help with Brexit
The transition period after Brexit ends this year. Several guidance documents have been published to help with the transition period and to help clarify the regulations after. The most recently updated documents relate to things such as pediatric investigation plans and pediatric studies, pharmacovigilance, marketing authorization, and bioequivalence/therapeutic equivalence studies. Click this link to search the published guidance documents. The current MHRA fees can be found here.
FDA has Released the User Fees for Fiscal Year 2021
FDA has published the user fees for fiscal year 2021 in the Federal Register. Some fees are reduced compared to fiscal year 2020. A few of the application fees are shown in the table below.
CDER Application Requiring Clinical Data
CDER Application Not Requiring Clinical Data
FDA Guidance on Electronic Medical Device Submissions
FDA has finalized the guidance document for electronic medical device submissions. The guidance discusses the types of submissions that must be electronic, the timetable and process for implementing the requirements, and the criteria for waivers or exemptions for electronic submissions.
FDA Plans to Resume Domestic Inspections
In a statement released July 10, FDA has stated plans to resume domestic on-site inspections the week of July 20. All inspections, except retail tobacco, will be pre-announced to ensure the safety of the investigator as well as the firm’s employees. Going forward, FDA will prioritize which inspections will occur based on risk and other factors. They have developed a rating system (COVID-19 Advisory Level) to assist in this prioritization.
MDR Extended 1 Year
The Parliament and Council almost unanimously approved the extension of the MDR for one year. An amendment to the original regulation was published in the Official Journal of the European Union in April, setting a new compliance date of May 26, 2021. It is important to note that this amendment does not apply to the IVDR and does not affect any of the regulatory requirements laid out by the MDR.
The World Health Organization Releases Draft Document on the Landscape of COVID-19 Vaccines
The World Health Organization has released a 7 page draft document that provides a current (as of July 2) landscape on the vaccines currently in development for COVID-19. The document provides information such as the type of vaccine, developer, and stage of development. There are over 100 vaccines present on the list, from companies all over the world.
EU and FDA Guidance on Clinical Trials During the Pandemic
The European Commission, EMA, and Heads of Medicines Agency have updated guidance for conducting clinical trials during the COVID-19 pandemic. The guidance is a harmonized set of recommendations focused on the safety of clinical trial participants throughout the European Union. It discusses topics such as initiating new trials, protocol changes/deviations, and how clinical sponsors should communicate issues to regulatory authorities.
The FDA has updated guidance that discusses general considerations for conducting studies during the COVID-19 pandemic. There are safety considerations and 23 questions and answers that cover topics such as suspending/continuing an ongoing study, protocol amendments/deviations, informed consent, and eCTD waivers.
FDA Documents on the Pandemic
The FDA has issued several guidance documents, letters, and FAQs to help manufacturers and sponsors during the COVID-19 pandemic. There are documents covering PPE, face masks, EUAs and several other topics. Click here to visit the FDA medical device page to see relevant news and assistance. There is also a page listing EUAs in various categories that may be helpful in determining if your device qualifies under an existing EUA or whether an application should be submitted.
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