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

SEPTEMBER 15, 2023

The FDA took no apparent action following this meeting, and another Citizen Petition was filed in 2015 Petitioners Hendeles and Hatton came back in 2015 with a new Citizen Petition , again asking for the removal of phenylephrine products from the Final Monograph for OTC nasal decongestant drug products.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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

As a result, products receiving approval due to their demonstrated safety and efficacy in the clinical trial setting may lack real-world effectiveness, with patients failing to see material benefit as they deal with persistent and severe side effects.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40

FDA Science Regulations Production 40