Manufacturing

Will more resources and new leadership fix FDA, or is a major overhaul in order?

The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

Readers give advice on their best approach to handling (batch) rejection

The biotechnology sector is occasionally described as a rainbow, with each sub sector having its own colour. But what do the different colours of biotechnology have to offer the pharmaceutical industry?

Conflict between departments costs money, wastes time and hinders strategy implementation. But we can reduce it and manage it if we understand it, says Dr Brian D. Smith.

A new year, all things being equal, is a time of looking to the future with positive intent and traditional bonhomie. At the very least, it suggests new beginnings. As we enter 2009, however, the world is moving into a major recession and things are far from equal.

Creating better pharmaceutical and medical products with packaging partnerships.

Paul Gardiner and Andrea Sobrio explain why most companies need 'organizational polygamy' to maximize profit and best serve their customers.

Hot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.

Reducing ecological footprint and achieving more sustainable production of pharmaceuticals could help create a better future.

Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.

The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The European Commission issued proposals last week to improve Europe's pharmaceutical market and patient safety.

Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the December 2008 edition from Spiroflow Systems and Sepha.

A surprising amount of the discovery and development life cycle is still based on manual and disconnected process steps.

Packaging a drug in a prefilled syringe may help extend a product's patent and distinguish it from competing products.

Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

A Centers for Disease Control and Prevention (CDC) study confirmed that severe adverse reactions reported in the fall and winter of 2007 resulted from heparin contaminated with oversulfated chondroitin sulfate (OSCS).

The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).

Industry experts are predicting that last week?s terror attacks in Mumbai, India may have at minimum some short-term effects on the pharmaceutical industry outsourcing business in that region.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.