Drug Channels

JUNE 21, 2021

MS, MBA, Director of Pharmacy Services, Emory Healthcare and Winship Cancer Institute Sophia Humphreys, PharmD., MHA, Director, System Pharmacy Clinical Services, Providence St. MS, MBA, Director of Pharmacy Services, Emory Healthcare and Winship Cancer Institute Sophia Humphreys, PharmD., Joseph Health Ameet Wattamwar, PharmD.,

Specialty Pharmacies 40

Specialty Pharmacies Pharmacy Science Marketing 40

Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Drug Channels

MAY 10, 2021

McCale III, MDY, RMC, Director, Market Access and Reimbursement , Akcea Therapeutics Shannon D. Choose between 3 Interactive Workshops on Day 2! Drug Channels readers are eligible for an exclusive savings of 10% off * the current rate by using promo code 21FRADC10 , be sure to reserve your seat today!

Pharmacy 40

Pharmacy Marketing Therapies Drugs 40

Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. Read AgencyIQ analysis of a recent listening session on the topic here. ]. and in Europe.

FDA 40

FDA Trials Regulations Therapies 40

Agency IQ

APRIL 12, 2024

In 2019, ICH announced a final concept paper proposing “a full rewrite and reorganization” of its E6(R3) Guideline on Good Clinical Practice, noting at the time that the intent of the update would include a focus on “increasingly diverse trial types” including DCTs [ Read AgencyIQ’s analysis of the Public Workshop on the ICH E6 renovation here ].

Regulations 40

Regulations Trials Science Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. The content will include both goals for enrollment of populations and rationales for those goals.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

Speaking of improving data in RWD sources, the HITAC annual report also points directly to the need to improve two areas of structural challenge for the FDA: consistent data standardization for laboratories , and better connectivity of pharmacy data “with the broader health IT ecosystem.”

FDA 40

FDA Laboratories Pharmacy Government 40

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. A year later, a similar workshop was conducted that included biologics and nonclinical models for efficacy, as well as modeling and simulation for dose-finding and dose optimization trials design.

FDA 40

FDA Science Clinical Trials Trials 40