Regulatory Oversight and Compliance

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.

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.

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.

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.

FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.