Quality Matters

JANUARY 23, 2023

Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies Investments to create a more resilient medicines supply chain and prepare for future public health emergencies are among key provisions of the mammoth $1.7

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Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

Quality Matters

SEPTEMBER 15, 2023

That way…we can do our best to communicate with you about how to best prepare a submission.” The ETP facilitates “early engagement” with FDA “before and during submission and assessment” of industry regulatory applications involving an AMT such as PCM, Fisher explained.

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Pharmaceutical Technology

MAY 3, 2023

In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma, heart disease, diabetes, and even the flu. However, that percentage of multiple first generics is not very high—approximately 10.6% from 2001 to 2022.”

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Generic Medicine Drug Development Communication Diabetes 98

Pharmaceutical Technology

DECEMBER 19, 2022

in 2022 to 1% in 2023 due to the “tightening of monetary and financial conditions”. Koerber-Walker discussed how the Inflation Reduction Act, introduced in 2022 , may benefit biologics companies’ funding plans going into the next year. Certain companies will struggle more than others with accruing investment from venture capital firms.

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Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Generic Medicine 69