Angie Drakulich

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

The US Food and Drug Administration?s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee?s findings.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

As we get ready to head into the new year, chief executive and financial officers may be making their wish lists for 2008. Grow revenue. Increase pipeline. Establish new facility abroad. Acquire small-sized generics company. And so forth. But why not add something "green" to the list?Why not consider ways to help the environment while aiming for success?

King Pharmaceuticals, and Acura Pharmaceuticals have entered into a license, development and commercialization agreement for the United States, Canada, and Mexico, encompassing a potentially wide range of opioid analgesic products utilizing Acura?s patented Aversion (abuse-deterrent) Technology platform.

As the mother of a 15-month-old, I was quite shaken last month to hear about over-the-counter cold medicines for children under age 2 being pulled off the shelves. Glued to the news, I wondered if the decongestant I had given my daughter when she was sick would have any negative impact on her long-term health.

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.

After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in FY2008.

Cardinal Health began construction on a $50 million expansion of its headquarters in Dublin, Ohio, on Oct. 3, 2007.

Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.

US Food and Drug Administration Commissioner Andrew von Eschenbach warned agency employees last Friday that 2,000 layoff notices could be coming as early as Sept. 21.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

The United States House of Representatives passed its version of the Patent Reform Act of 2007 (H.R. 1908) in a 220–175 vote.

Early this month, Congress is expected to debate what some companies are calling the most significant changes to the United States patent system in 50 years.

When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.

Last week, it was reported that the US Food and Drug Administration may start outsourcing jobs to private companies.

China will spend more than $1 billion to improve its food and drug safety by 2010 and give its State Food and Drug Administration more oversight powers.

The US House of Representatives passed legislation permitting importation of lower-cost prescription drugs from other countries, including Canada, Australia, and Europe.

Rebecca Fuller, president of BioAssist Consulting Services (Alberquerque, NM) provided an attentive audience at the 2007 Pharmaceutical Technology annual conference with a number of practical ways to apply, grow, and improve pharmaceutical manufacturing with risk management approaches.

With more and more people in the industry sending their manufacturing processes elsewhere, it’s important to find a trustworthy contract organization and to know what to expect-and how to deal with-that organization. R. Christian Moreton, Ph.D., discussed this topic at the 2007 annual conference of Pharmaceutical Technology.

Gerry Boushelle, associate director of global supply chain clinical-supply manufacturing in Pfizer’s (New York) global research and development division, presented a case study of the company’s implementation plan, conducted during 2006, at the 2007 Pharamaceutical Technology annual conference.

A US delegation of health officials is visiting China this week on a fact-finding mission regarding food and drug safety.

Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.

Industry and regulatory experts provide advice on inspection preparation and best practices.

The IBM Corporation signed a $1.4-billion global outsourcing deal with AstraZeneca PLC (London). The seven-year agreement, which renews and expands on a current contract, covers the provision of IT infrastructure services to 60 countries and additional functions within AstraZeneca.

The People?s Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths.

Novartis Vaccines plans to produce approximately 40 million doses of its ?Fluvirin? vaccine for distribution in the United States during the 2007?2008 flu season.