STAT

JUNE 6, 2023

After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some   cancer medicines that are in short supply.

Chemotherapy 101

Chemotherapy FDA Documentation 101

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

FDA 90

FDA Chemotherapy Documentation 90

STAT

AUGUST 1, 2023

Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. These serious violations of manufacturing protocols were revealed in a July 28 warning letter sent by the U.S.

Chemotherapy 98

Chemotherapy Documentation FDA 98

pharmaphorum

FEBRUARY 8, 2022

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. ” While ODAC could still decide to back the drug at the meeting, the FDA isn’t beholden to follow its experts’ advice.

FDA 52

FDA Documentation Chemotherapy 52

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 1942 – Chemotherapy moves from trenches to treatment . Before the birth of bone marrow transplants, patients were often treated using chemotherapy, which could be used to kill cancer cells.

Chemotherapy 98

Chemotherapy Immunization FDA Documentation 98

Pharmaceutical Technology

MARCH 30, 2023

On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

FDA 98

FDA Insurance Chemotherapy Documentation 98