This week, FDA published a draft guidance on the use of registries to support regulatory decision-making. In this guidance, titled "Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and...more
As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce...more
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that...more
With the FDA’s emergency use authorization (EUA) and now widespread availability of multiple COVID-19 vaccines in the United States, an increasing number of public and private entities are considering requiring or have...more
On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.
This final rule takes...more
Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.
Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the...more
FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.
This May Guidance supersedes the guidance, “Enforcement Policy for Face...more
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....more
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,...more
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous February 29, and March...more
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...more
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...more
This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic. As reported in the news on a...more
Should Ibuprofen Be Used to Combat Coronavirus Fever?
The mechanism of attack by the novel coronavirus SARS-CoV-2 on human cells is thought to involve a specific region, known as the receptor-binding domain (RMD), located...more
FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices....more
As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more
As part of its ongoing effort to address the critical shortage of Personal Protective Equipment (PPE) needed to address the COVID-19 pandemic, FDA has issued an Enforcement Policy to help expand the availability of surgical...more
As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more
As part of its ongoing efforts to address the many healthcare challenges posed by the COVID-19 pandemic, FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand...more
News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.
Masks, ventilators, and gowns are...more
Food Safety
On March 9, the European Food Safety Authority announced that there is no evidence that food is a source or transmission route for coronavirus. FDA has taken the same position, both in a stakeholder briefing held...more