Perspectives on Food, Drug, Medical Device & Cosmetic
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Partner Karen Carr will serve as a panel speaker at the 2020 FDLI Annual Conference in October. Karen’s session is titled “Emerging Technologies: Regulatory Oversight of Intentional Genomic Alterations in Animals.”
The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements.
The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities.
On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.
AgTech Partner Karen Carr recently participated in a webinar about the US Department of Agriculture’s final rule addressing regulation of agricultural biotechnology products issued on May 15, 2020.
FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.
The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.
On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industries.
On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home.
What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China.
The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and, as a result, those who might now have immunity, at least temporarily. Howev
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic.
This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment (PPE) that pose supply challenges due to high demand.
Congress Enacts Sweeping Reforms to Over-the-Counter Drug Regulation as Part of COVID-19 Response Bill
For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) on March 27, 2020.
As the United States begins to see positive signs that mitigation efforts such as stay-at-home orders and social distancing are working, the question of when people can return to work and resume normal activities is one of the most critical issues facing the country – and indeed the world.
FDA continues at a relatively fast clip to issue policies intended to help solve a dire problem: the ongoing need to expand the availability of certain medical products in the US that are critical to addressing the COVID-19 pandemic.
When Will All This End? New Modeling Looks at Control Measure Duration and Resurgent Infections of COVID-19
On April 14, 2020, the journal Science published on-line a “First Release Notification” paper entitled “Projecting the transmission dynamics of SARS CoV-2 through the postpandemic period” by scientists from the Departments of Epidemiology and of Immunology and Infectious Diseases at the Harvard Scho
As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected patient.
FEMA has exercised its delegated authority under the Defense Production Act to issue a temporary final rule to prohibit the export of five types of medical PPE that the US government previously identified as scarce and threatened material in the COVID-19 pandemic.
This updates our prior Alert regarding the importation and distribution of respirators and other masks to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.
On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments that have the potential to be both safe and effective.