Quality Systems

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Hospitals form not-for-profit drug company to combat drug shortages and high prices.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.

Drug manufacturers can improve use of quality agreements in contract manufacturing.

The President described US drug costs as unfair and stated that prices will come down.

Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.

FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.

The latest continuing resolution funds the government for three weeks.

The FDA center released its list of planned guidance documents for the rest of the year.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.