Tag Archives: Life Sciences and Medical Technologies

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.

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.

FDA Unveils Program to Expedite Coronavirus Treatments

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

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

FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency.  FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. AshFrederick R. BallPatrick C. Gallagher, Ph.D.Jonathan LourieVicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

USTR Offers New Section 301 Exclusions for COVID-19 Medical Products

Since our previous two Alerts, on March 13 and 20, describing actions taken in recent weeks by the U.S. Trade Representative (USTR) to exclude numerous medical products imported from China from Section 301 tariffs, the USTR has announced it will accept new Section 301 exclusion requests relating to other products that can be used in the battle against the coronavirus (COVID-19). Such exclusion requests can be submitted for any product that can be used to address the COVID-19 pandemic that has not yet been granted by the USTR, including products with previously denied or currently pending exclusion requests, as well as for products for which requests have not been filed.

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

FDA Guidance Aims to Accelerate Availability of COVID-19 Tests

On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.

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