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Biopharmaceutical Manufacturers

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Kilpatrick

The Supreme Court Leaves Skinny Labels to Another Day

Kilpatrick on

The Supreme Court recently rendered two important decisions for the biopharma industry. In the first decision, the Supreme Court ruled on enablement of genus claims for therapeutic antibodies, unanimously affirming the...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] The Future of Telehealth and Its Implications for Biopharmaceutical Firms - December 14th, 3:00 pm - 4:00 pm ET

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The COVID-19 pandemic has entrenched telehealth into the fabric of modern health care...more

Rivkin Radler LLP

OIG: Biopharma Company’s Provision of Free Genetic Tests Does Not Warrant Sanctions Under AKS

Rivkin Radler LLP on

With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more

ArentFox Schiff

OIG Issues Advisory Opinion Approving Biopharmaceutical Manufacturer’s Sponsorship of Free Genetic Testing and Counseling

ArentFox Schiff on

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

Goodwin on

It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Morgan Lewis

FDA New Normal: Back to School with the A, B, CGMPs

Morgan Lewis on

The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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