Susan Haigney

Draft guidance combines and supersedes previous guidance documents.

INTERPHEX 2013 begins later this month and Pharmaceutical Technology will be previewing the action in the weeks to come.

Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report.

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation.

Developing and maintaining the right labor pool is an ongoing challenge for any industry, and it is one that the pharmaceutical industry also is facing. Recent attention in the pharmaceutical industry has focused on the restructuring that has occurred and that is still occurring among the large pharmaceutical companies.

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry.

PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation.

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation.

Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices.

USP revises labeling requirements for Heparin.

FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy.

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy.

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin.

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines.

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

PDA Revises Technical Report on Sterilized Products

The Parenteral Drug Association has released guidance on the detection and mitigation of 2,4,6-tribromoanisole and 2,4,6-trichloroanisole taints and odors in pharmaceutical and healthcare products.