COVID-19 Vaccine Approval Further Opens Door for Employer Mandates

On August 23, the FDA granted full approval for the Pfizer-BioNTech COVID-19 vaccine for individuals age 16 and older. Some employees who expressed vaccine hesitancy because the FDA approval was only an emergency use authorization (EUA) may have less hesitancy now. This may be a good time, through employee education, to once again encourage your employees to get vaccinated.

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

New FDA Guidance Embraces “Remote Interactive Evaluations” but Stops Short of Permitting Virtual 704(a) Inspections

On April 14, 2021, the U.S. Food and Drug Administration issued formal guidance addressing the circumstances under which it will conduct “remote interactive evaluations” of drug manufacturing and bioresearch monitoring facilities in light of the ongoing COVID-19 public health emergency, which has pushed many previously in-person activities onto virtual platforms over the past 13 months.

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

CDC Advisory Committee Issues Recommendations for Initial COVID-19 Vaccine Prioritization

The afternoon of December 1, 2020, marked an important milestone in the fight against the coronavirus pandemic. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) voted 13-1 to approve recommendations to prioritize distribution of the initial doses of COVID-19 vaccines. ACIP took an unusual step, issuing the recommendations before the FDA issues emergency use approval (EUA) of any COVID-19 vaccines so that the recommendations could assist states in developing their own vaccine distribution plans.

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 Issues Temporary Policy on Distribution of Drug Samples During COVID-19

In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act.

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.

FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

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

FDC Changes OTC Drug Review Process in Response to CARES Act

Most of the hundreds of pages comprising the CARES Act, signed into law on March 27, 2020, concern measures for directly counteracting COVID-19 and assisting those dealing with economic consequences of the pandemic. Yet tucked away in Subtitle F of the legislation are a number of provisions—now law—which streamline FDA’s over-the-counter (OTC) drug review process. These changes are likely to lower the regulatory burden of getting a product through the OTC drug review process and provide incentives of market exclusivity for companies who do.

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

Webinar: How COVID-19 Is Affecting Life Sciences and Medical Technologies

Duane Morris will be hosting the webinar, “How COVID-19 Is Affecting Life Sciences and Medical Technologies,” on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (Eastern).

Join Duane Morris attorneys for a discussion on how the life sciences and medical technologies industry is responding and adapting to the COVID-19 pandemic, including:

  • FDA’s Emergency Use Authorizations (EUAs) for devices and diagnostics testing policies
  • Public Readiness and Emergency Preparedness Act (PREP Act) immunity from liability
  • Implications on intellectual property, such as patent strategy, in biotechnology and pharmaceuticals
  • License and collaboration agreements in the wake of COVID-19

For more information and to register, please visit the firm website.

FDA-Approved Anti-Malaria Drugs for COVID-19 Treatment Fall Within Liability Shield of the PREP Act

The Food and Drug Administration (“FDA”) gave emergency approval this week to two (2) anti-malaria drugs, hydroxychloroquine and chloroquine, to be used for treatment of COVID-19 patients.  Despite the limited studies as to the benefits of these drugs and the well-known risks of these drugs, the FDA took the position that, under the current circumstances, the potential benefits and effectiveness outweigh the risks.  While the FDA is conducting a trial as to the effectiveness of these drugs, millions of doses have already been shipped to hospitals nationwide for administration in an attempt to slow the spread of COVID-19.

To read the full text of this post by Duane Morris attorney Brittany Wakim, please visit the Duane Morris Products Liability Blog.