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.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals International 80

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.]

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

FDA Law Blog: Biosimilars

JANUARY 24, 2024

If this vision is achieved, the United States can bring innovative biotechnologies and products to markets faster while building a more robust supply chain ecosystem. capacity and technologies to support small molecule API production, including the impact of key starting material availability on U.S.

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Small Molecule Government Production Pharmaceuticals 69