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. At that time, FDA flagged concerns with functional unblinding and inherent expectation bias.

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The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Scientists documented a significant depletion of long-lived plasma cells, a reduction of interferon type I activity, and a down-regulation of T-cell transcripts associated with chronic inflammation. Bioelectronic Platform.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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The Pharma Data

APRIL 8, 2021

EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Applications are under review with numerous regulators. At this time, EVRYSDI has been approved in 38 countries and submitted in a further 33 countries. Europe and Japan.

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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. And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. In July, a new contract notice indicated that this is an area of interest for FDA as well.

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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.

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Agency IQ

AUGUST 16, 2024

Today, though, patients, clinicians, and regulators expect more. What came before this final guidance Dose optimization for oncology products has been an issue flagged for improvement even prior to the creation of FDA’s Oncology Center of Excellence (OCE) in 2017.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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