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Research and Development Infectious Diseases 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

Hogan Lovells

Biden executive order kicks off government-wide review of supply chains

Hogan Lovells on

On 24 February 2021, President Biden issued an Executive Order (EO) that launches an examination of America’s supply chains. See EO No. 14017, 86 Fed. Reg. 11849 (Feb. 24, 2021). The Administration’s ultimate goal is...more

Morgan Lewis

FDA Issues More Guidance on Gene and Cell Therapy Products

Morgan Lewis on

January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more

Hogan Lovells

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

Hogan Lovells on

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more

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