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Public Health › Biologics › Life Sciences

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

Morgan Lewis - As Prescribed on

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

Mintz - Health Care Viewpoints on

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

Hogan Lovells

FDA issues list of essential medicines and countermeasures required under Buy American Executive Order

Hogan Lovells on

Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more

McDermott Will & Schulte

Product-by-Process Analysis Applies to Method of Treatment Claims

McDermott Will & Schulte on

In a case relating to use of recombinant human interferon-ß (IFN-ß) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” analysis applies even when...more

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

Seyfarth Shaw LLP on

China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more

Seyfarth Shaw LLP

FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

Seyfarth Shaw LLP on

To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020.  ...more

Sheppard Mullin Richter & Hampton LLP

Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison...

Sheppard Mullin Richter & Hampton LLP on

2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

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