News

The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Production problems come in all shapes, sizes, and ... species.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

Molecules called "chaperones" facilitate correct protein folding.

Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing.

Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.

The first 2 weeks of October witnessed the closure of CPhI (30 September–2 October) and the whole of Biotechnica (7–9 October). Pharmaceutical Technology Europe had a presence at both events, which took place in Frankfurt and Hanover (both Germany), respectively. With record-breaking numbers of attendees, roundtables and conferences of the highest quality, and exhibitors from bio and pharma companies from all over the world, these two events are a must in the calendars of many in the biotech and pharmaceutical industries.

Together, Europe and the US account for more than 70% of the global pharmaceutical market, and the growth of these markets is heavily dependent on distribution systems.

The US Government Accountability Office (GAO) released a report last week that examines and provides recommendations for the US Food and Drug Administration's foreign inspection process, including the agency's data management, inspection frequency, and oversight of problems identified during inspections.

The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

Merck plans to cut approximately 7200 positions as part of its 2008 restructuring plan, according to an Oct. 22 release focused on the company's third-quarter financial results.

Pfizer and Lilly recently resolved issues related to their marketing practices for certain products.

Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more...

Pfizer and UCB formed a technology company named Cyclofluidic with the aim of accelerating the drug-discovery process.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

The US Department of Health and Human Services (HHS) will send the first Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website.

Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more...

Also, Millipore opens new membrane-casting manufacturing facility in Ireland; Surface Logix appoints Keith Dionne president, CEO, and a member of the board; more...

According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive.

FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs.

During the past several months, Pharmaceutical Technology has been covering the US Food and Drug Administration's rulemaking on over-the-counter (OTC) cough and cold medications for children.

At a public meeting, the Medicare Payment Advisory Commission (MedPAC) discussed its recommendation that Congress establish a national database to publicly reveal financial relationships between physicians and the pharmaceutical industry.

John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.

The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern.

Integrating MES with enterprise resource planning (ERP) systems can bring companies greater control over production than before and make manufacturing processes more flexible.

A bill that would require country-of-origin labeling for active and inactive ingredients for all prescription and over-the-counter pharmaceuticals was introduced in the US Senate last week.

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use.