Novartis presented an update on its long-term strategy, performance, and growth outlook last week, which revealed that the company is on track to deliver the strategic priorities it had set out in 2010.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Lechler and National Bulk Equipment.

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

In our manufacturing process, we are running into issues with our vial stoppers clumping in the feeder bowl. How can we ensure that the stoppers go through smoothly without clumping up?

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement aimed at a stakeholder meeting being held at the US Department of Health and Human Services to address the growing issue of drug shortages in the United States.

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.

AmerisourceBergen Completes the Acquisition of IntrinsiQ; Xcelience Expands its Manufacturing and Packaging Services; and More.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.

The UK's Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council to invest up to £9 million ($14.2 million) in grant funding with the aim of driving proof-of-concept ideas to pilot technology demonstration for healthcare.

FDA Makes Organizational Changes Within CDER.

Deborah Autor testifies before US Senate HELP committee on requested authorities to improve pharma supply chain.

GSK, Anacor Expand R&D Collaboration; Xoma Announces Management Changes; and More.

USP Expands Presence in India.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Sweden's Medical Products Agency issues a report calling for strengthening environmental standards for pharmaceutical production within the European Union.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Pfizer has completed its cash tender offer for the biopharm company Icagen after extending its initial deadline.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

A report commissioned by FDA evaluates the QbD program.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

A summary of the latest steering committee and expert working groups' meeting.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

Valeant Agrees to Acquire Afexa Life Sciences; Merck KGaA Names Robert Yates President of Millipore Division; and More.

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.