OSHA Issues Comprehensive COVID-19 Guidance with More Likely to Come

On January 21, 2021, President Biden signed an Executive Order on Protecting Worker Health and Safety. Pursuant to the executive order, OSHA issued guidance on January 29, 2021 that includes extensive information for structuring and implementing an effective COVID-19 Prevention Program to protect their workforces.

The guidance states that it is “advisory.” However, failure to follow the guidance may expose employers to, among other risks, OSHA citations and substantial penalties for violating the OSHA general duties clause. In this regard, the executive order calls for increased OSHA enforcement and the guidance is a starting point for such enforcement.

To read the full text of this Duane Morris Alert, please visit the firm website.

EEOC Updates Guidance on Employer COVID-19 Vaccination Policies

In our December 15, 2020, Alert, we advised that the Equal Employment Opportunity Commission (EEOC) would provide updates to its COVID-19 guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” to address employer rights and responsibilities related to COVID-19 vaccination policies. Right after our Alert was issued, on December 16, 2020, the EEOC updated its COVID-19 guidance with questions and answers for employers who seek to have their employees inoculated against this deadly virus.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

To read the full text of this Duane Morris Alert, please visit the firm website.

Interim CDC Guidance Lays Out Business Plans to Reopen Certain Sectors During COVID-19 Pandemic

As states and communities begin the process of reopening in the wake of the COVID-19 pandemic, the Centers for Disease Control and Prevention (CDC) has released business plans to provide interim guidance to certain programs and industries during the reopening process. The CDC released its proposed business plans for the following programs and industries: child care programs; schools and day camps; communities of faith; employers with vulnerable workers; restaurants and bars; and mass transit administrators.

To read the full text of this Duane Morris Alert, please visit the firm website.

Interim Guidance on Treatment of COVID-19 Released by American Thoracic Society, Including Discussion of Controversial Hydroxychloroquine Therapy

The American Thoracic Society (ATS) on April 3, 2020 published a guidance document providing several suggestions for treatment of COVID-19.  The document, entitled “COVID‐19: Interim Guidance on Management Pending Empirical Evidence,” was developed by an ATS-led international task force and addresses several recently publicized potential treatment regimens.

To read the full text of this post by Duane Morris attorney Alison Rosenblum, please visit the Duane Morris Health Law Blog.

Department of Labor Issues Initial Guidance Regarding the Families First Coronavirus Response Act

On March 24, 2020, the U.S. Department of Labor’s Wage and Hour Division (WHD) issued initial guidance on the Families First Coronavirus Response Act (FFCRA), which was signed into law on March 18, 2020. (For more information, see our prior Alert on the requirements of FFCRA.) The WHD’s guidance indicates that regulations are also forthcoming in April, but these regulations likely will not be issued before FFCRA takes effect.

To read the full text of this Duane Morris Alert, please visit the firm website.