2022, Biosimilars, Drug Development and Pharmacokinetics

What recent paediatric guidelines mean for drug developers

Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.

Drug Development

Drug Development Clinical Pharmacology Pharmacokinetics Drugs

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA

FDA Science Biosimilars Production

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route.

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

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