News & Analysis as of

Food and Drug Administration (FDA) Crisis Management

Hogan Lovells

PREVENT Pandemics Act to build pandemic capabilities and implications for medical product developers

Hogan Lovells on

Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly...more

ArentFox Schiff

Is Delta Taking Over?

ArentFox Schiff on

On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States. In that Alert, we included the prediction by the Centers for...more

American Conference Institute (ACI)

[Virtual Event] Food Law – Regulation, Compliance and Litigation - May 12th - 13th, 8:15 am - 3:45 pm CDT

The food industry’s most comprehensive legal and regulatory conference, Food Law – Regulation, Compliance and Litigation, is returning this spring in a unique, interactive virtual format. Key stakeholders will discuss how to...more

American Conference Institute (ACI)

[Virtual Event] 4th Advanced Summit on Food Law – Regulation, Compliance and Litigation - July 15th - 16th, 8:00 am - 5:05 pm CDT

Network and brainstorm with top regulatory and compliance executives and legal counsel. ACI’s Food Law conference is a unique, interactive forum where key legal, regulatory and compliance stakeholders for the food industry...more

McDermott Will & Emery

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

McDermott Will & Emery on

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

Hogan Lovells

First emergency use authorization for COVID-19 drugs may open door for more EUAs

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more

Morgan Lewis

FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

Morgan Lewis on

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

Morgan Lewis on

The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Furia Rubel Communications, Inc.

Truth in Advertising, Cannabis, and the Importance of a Crisis Plan and Social Media Policy

If you’ve ever wondered whether Big Brother is watching you online, the answer is yes. I’m not just referring to the big data and privacy breaches such as Equifax’s recent $700 million settlement which has been reported in...more

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