Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. Adapted from Harth S et al. (8) 8) under a CC BY-NC-ND 4.0.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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

The Premier Consulting Blog

OCTOBER 26, 2022

The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

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