News & Analysis as of

Food and Drug Administration (FDA) Clinical Trials Supply Chain

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

Morgan Lewis on

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

Woodruff Sawyer

How to Manage Exposures When Commercializing a Life Sciences Product

Woodruff Sawyer on

The road to commercializing a life sciences product is a long one, spanning years to perform research, develop the product, conduct clinical trials and testing, and receive approval from the Food and Drug Administration...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

MoFo Life Sciences on

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 # 11

Hogan Lovells on

In Washington - House Speaker Nancy Pelosi (D-CA) is calling Democrats back from the August recess to vote on legislation that would prohibit operational changes at the U.S. Postal Service that could curtail mail-in...more

McDermott Will & Schulte

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

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

Goodwin

COVID-19 Pandemic May Impact Biosimilars

Goodwin on

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars.  In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and...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

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