The Premier Consulting Blog

NOVEMBER 16, 2022

One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects. On September 14, 2018, the U.S.

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Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. That “common and widely known side effect” of many “chemotherapy drugs,” id. Two other oldies but goodies are Plummer v.

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Drug & Device Law

JANUARY 4, 2024

The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8). 247d-6d(b)(8). Alabama State Board of Pharmacy , 61 F.4th 4th 902, 905 (11th Cir.

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