Drug Discovery World

NOVEMBER 29, 2022

The curriculum and assessment structure is based on what the students will need to thrive in the drug development sector, with all scientific topics taught with the drug in mind first. Pharmacokinetics: How the body handles drugs. Pharmacodynamics: How drugs exert their effects on the body. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

Therapies 98

Therapies FDA Trials Clinical Trials 98

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First: Psychotherapy is a major quandary at best, and a landmine at worst.

FDA 40

FDA Trials Regulations Therapies 40

Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. A description of the project and summary of outcomes will be posted on the FDA website.

FDA 40

FDA Science Clinical Trials Regulations 40

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. The workshop is also discussed in Cell & Gene here and here.

Therapies 59

Therapies Engineering Production FDA 59