Alta Sciences

JANUARY 31, 2025

A non-profit organization, STC was founded in 1965 with 15 scientists from Montral-based pharmaceutical companies. It owned the societal name of the Canadian Association for Research on Drug Safety. The STC is an intimate gathering of scientists with a fervor to acquire and apply knowledge in toxicology.

Cell Biology 52

Cell Biology Pharmaceutical Companies Clinical Research Government 52

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

Science 40

Science FDA Drugs Production 40

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

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 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Drug Target Review

MARCH 20, 2025

These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication. “We anticipate ASTER will complete in early 2027 and could form the basis for approval in the treatment and prevention of venous thrombotic events in patients with cancer,” Bloomfield said.

Therapies 52

Therapies Trials Clinical Development FDA 52