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 102

Chemotherapy FDA Documentation 102

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

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

European Pharmaceutical Review

JULY 4, 2023

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options.

Communication 98

Communication Chemotherapy Documentation Dosage 98

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 30 June 2016.

Chemotherapy 52

Chemotherapy Documentation Dosage Labelling 52