Quality Systems

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.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

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.

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.

Labels must have special features to prevent tampering of pharmaceutical packaging.

The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.

The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.

The company is voluntarily recalling product because of glass particles found in vials.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.

Bio/pharma professionals manage expectations amid industry uncertainty.

Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.