Search
USFDA Guidance: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
The U.S. Food and Drug Administration (FDA) has issued the September 2026 draft guidance “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. The guidance provides recommendations for sponsors and applicants planning studies to evaluate how hepatic impairment affects the pharmacokinetics (PK) and, where appropriate, pharmacodynamics (PD) of drugs, including therapeutic biological products. It is a draft
Sharan Murugan
19 hours ago4 min read
USFDA Guidance: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
Immunogenicity is an important consideration in the development and regulatory evaluation of many biological products and therapeutic proteins. The formation of anti-drug antibodies (ADAs) can influence a drug's pharmacokinetic profile, potentially affecting drug exposure, efficacy, and safety. To support consistent regulatory assessment, the FDA issued the guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug.
Sharan Murugan
Jun 223 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...
Sharan Murugan
Mar 20, 20242 min read