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Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

[Webinar] Life Sciences Webinar: Key Enforcement & Compliance Issues Impacting Your Business - June 17th, 1:00 pm - 2:00 pm ET

One of the few constants in the evolving government enforcement landscape is a focus on life sciences companies and their interactions and financial relationships with providers. In this final installment of our three-part...more

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Digital Health - June 8th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - November 17th, 8:00 am - 2:00 pm EST

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 3 - November 10th, 12:00 pm - 1:00 pm EST

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 2 - October 27th, 12:00 pm - 1:00 pm EDT

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 1 - October 20th, 12:00 pm - 1:00 pm EDT

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

Fast Track for COVID-19 Drug and Vaccine Approval in the United States and Europe

The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more

FDA Issues Enforcement Policy for Digital Health Therapeutic Devices for Psychiatric Disorders During COVID-19

The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...more

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

CARES Act Reforms to Address Drug and Device Shortages and Updates to the OTC Drug Monographs

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more

FDA Update: Enforcement Policies for Gowns, Gloves, Sterilizers, Disinfectant Devices and Air Purifiers

In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more

FDA Issues FAQs on 3D Printing of Medical Devices, Accessories, Components and Parts During the COVID-19 Pandemic

On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more

FDA Opens Submissions for COVID-19 IND Applications

As part of its initiatives to expedite access to investigational drugs or biologics for the treatment of Coronavirus (COVID-19), on March 24, 2020, the US Food and Drug Administration announced that healthcare providers may...more

FDA Issues Enforcement Policies for Face Masks and Respirators; Emergency Use Authorization for Ventilators

In a series of notices and enforcement-policy statements, the FDA has announced additional efforts to address the critical shortage of face masks, filtering facepiece respirators (FFRs) and ventilators in response to the...more

FDA Seeks to Improve Ventilator Access, Relaxes REMS Requirements During COVID-19

The US Food and Drug Administration (FDA) announced several initiatives to increase access to ventilators and other respiratory devices during the Coronavirus (COVID-19) pandemic, as well as relaxed enforcement of certain...more

FDA Offers Guidance on Clinical Trials During COVID-19 Pandemic

The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more

FDA Update: FDA Enforcement Policy, Non-Invasive Remote Monitoring Devices

On March 20, 2020, the US Food and Drug Administration announced updates to its enforcement policy on the use of non-invasive remote monitoring devices, specifically for uses designed to support patient monitoring during the...more

FDA Offers Laboratories, Manufacturers New Flexibility to Expedite COVID-19 Testing

On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

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