Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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Pharmaceuticals Small Molecule Science FDA 40

FDA Law Blog: Biosimilars

JANUARY 24, 2024

is identified as “Improving Supply Chains for Critical Drugs,” and states: “ In 5 years, deploy broad synthetic biology and biomanufacturing capabilities to produce at least 25% of all active pharmaceutical ingredients (APIs) for small molecule drugs ” (emphasis added). The first goal under Theme 1—Goal 1.1—is

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Small Molecule Government Production Drugs 67