Articles

  • Sep 14, 2023 | outsourcedpharma.com | Louis Garguilo |Madeleine Giaquinto |Desline Barber |IDT Biologika

    Bio And The Business Of Aging With Life Biosciences' Jerry McLaughlinThe fountain of youth might be a fantasy, but the science behind manipulating the biology of aging has become big business. But does the investment community understand and embrace the concept? Will regulatory agencies view aging as an indication that warrants therapeutic review? And how does a legitimate biopharma company separate itself from the consumer-packaged anti-aging and cosmetic procedures markets?

  • Aug 16, 2023 | outsourcedpharma.com | Madeleine Giaquinto |Louis Garguilo

    By Madeleine Giaquinto, J.D., Greenleaf Health In June 2023, with a dwindling number of months before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met, impacted drug supply chain stakeholders received some additional insight into the FDA’s potential DSCSA enforcement approach through a second-of-its-kind warning letter.1 The warning letter, dated June 8, 2023, was issued to Safe Chain Solutions, LLC and addresses DSCSA violations related to the wholesale...

  • Aug 10, 2023 | pharmaceuticalonline.com | Madeleine Giaquinto

    By Madeleine Giaquinto, J.D., Greenleaf Health In June 2023, with a dwindling number of months before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met, impacted drug supply chain stakeholders received some additional insight into the FDA’s potential DSCSA enforcement approach through a second-of-its-kind warning letter.[1] The warning letter, dated June 8, 2023, was issued to Safe Chain Solutions, LLC and addresses DSCSA violations related to the wholesale...

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