Agency IQ

SEPTEMBER 15, 2023

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.”

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

FEBRUARY 8, 2021

Additionally, ZYTIGA ® was approved for the treatment of high-risk mCSPC by the European Commission on November 20, 2017 and by the U.S. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40