FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions.

Therapies 59

Therapies Engineering Production FDA 59

Drug Target Review

OCTOBER 10, 2024

Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinical development and escalate costs. In conclusion, over-reliance on healthy donor material in cell therapy development creates a precarious foundation for clinical translation.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. Adapted from Harth S et al. (8)

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Premier Consulting Blog

OCTOBER 26, 2022

During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing.

Production 40

Production Assay Development Clinical Supply Engineering 40

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40