Viewpoints

The "why" things are done in this industry is just as important as the "what"and "how."

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.

Thin are the lines that separate stability, statistics, and chaos.

Thanks to the media, Nobel Laureates are underrated, undervalued, and simply uncool.

The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.

Change is inevitable, as is contract manufacturing. But which companies will survive the drifts?

Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.

Courts are denying the terminally ill access to experimental drugs, leaving many with no options.

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Poor processing and misguided projections lead to trashed product.

In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?

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.

Feedback is urged on USP's proposed revisions to the General Notices.

By vetoing stem cell research funding, the President is vetoing potentially life-saving treatments.

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.

Production sometimes follows the law of supply and reprimand.

Here's a look at some of the most interesting and thematic responses you-our readers-provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

The good ol' days weren't always good.

Thirty years ago, the world was a very different place; so was the pharma industry.

Look ahead to keep from falling behind.

Global corporate citizenship can go a long way.

Perhaps Congress can help FDA meet its multiple oversight demands.

Signature authentication technology has evolved to become a stong tool for improving confidence in verification.

Breaking up is easy to do.

USP exercises a vigorous standards-setting process that draws on both public comments and meticulous scientific review.

A recent benchmarking report on pharmaceutical manufacturing raises questions about the performance of contract manufacturers, but further analysis also raises concerns about the process and data used to arrive at this conclusion.

Inaccuracies in Chapter ‹1072› of the current USP 29 reveal problems in USP's revision and proofreading process.

Mishaps in packaging labels serve as a reminder: the recall is in the details.

To effectively grow in the biotech industry, companies must develop multiphase plans that focus on regulation and efficiency.

Just because the wheels are turning doesn't mean they're going forward.