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Regulatory Focus™ > News Articles > The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

Posted 06 April 2015 | By Alexander Gaffney, RAC

The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

It's already been a busy, busy year here at Regulatory Focus. During the first quarter alone, more than a quarter million of you have read more than half a million of our articles—a new record for Focus, and hopefully a testament to the value of the content we're producing on a daily basis. But which articles have attracted your collective attention the most? Read on to discover the top 10 articles in Focus so far this year.

The Top 10

10.) FDA Launches New Drug Quality Office, With Goal of Improving the Pharmaceutical Industry

FDA's Janet Woodcock has for years been a fierce advocate of improving drug quality, both at FDA and within the pharmaceutical industry. In January, Woodcock took a major step toward actualizing her advocacy with the opening of FDA's Office of Pharmaceutical Quality (OPQ), which will assume control over all drug quality measures at FDA. Focus explains the role of OPQ in depth, and also breaks down some of the potential benefits—and pitfalls—the office might bring to the pharmaceutical industry.

9.) FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year

Unless you read a lot of regulatory documents, it can be difficult to determine which information is brand new and which is last year's news. Luckily, we read a lot of regulatory documents, and were able to break this story about FDA's plans to release two widely-sought-after documents in 2015: A guidance on biosimilars labeling and another guidance on generic opioids.

8.) FDA Commissioner Margaret Hamburg to Resign Next Month

Former FDA Commissioner Margaret Hamburg was one of the agency's longest-serving leaders. News of her impending resignation in February created waves within the regulatory affairs world and raised some serious questions. Who will succeed Hamburg on a permanent basis? What does her resignation means for the agency? What does her resignation mean for the industries FDA regulates?

7.) India's Data Integrity Problems

If you haven't been paying close attention, you might not know that FDA has been cracking down on Indian pharmaceutical companies, and in particular over one regulatory deficiency: Data integrity. Our widely-read roundup of data integrity problems affecting India's pharmaceutical companies is an essential resource for understanding why data integrity problems matter, and why FDA is making a big deal out of the issue.

6.) The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

News isn't the only popular thing on Regulatory Focus. This quarter saw thousands of you click on our guide to finding pharmaceutical, medical device and biotechnology information related to FDA. The guide, which we created from years of painstaking experience, is an excellent way to find regulatory information and locate FDA's disparate databases.

5.) FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

FDA regularly releases new so-called "bioequivalence" standards meant to make it easier for generic pharmaceutical companies to bring their products to market. It's especially noteworthy when these standards relate to still-protected products. In March, we dug into FDA's latest batch of bioequivalence standards, which included explanations of how 38 drugs—including Stendra, Belviq, Kalydeco and Brilinta—could get FDA's approval.

4.) FDA Cracks Down on Facebook Marketing with Four New Letters to Companies

FDA's regulation of social media is a perennially popular topic here at Focus. In early March, we set out to examine a new batch of Warning Letters issued by FDA to six different companies regarding their promotions on social media. We found that FDA is paying much closer attention to companies' Facebook pages to generate evidence that a product is misbranded.

3.) In Major Decision, India Rejects Patent on Gilead's Hepatitis C Drug Sovaldi

The US isn't the only market where regulators are making big news. In January 2015, Gilead Sciences received word from India's patent office that the company's patent on its blockbuster drug Sovaldi would be denied due to a lack of evidence that "minor changes in the molecule" substantially improved the drug. Our explanation of the decision went beyond the headline to explain how India's patent court functions and the reason officials would deny the patent.

2.) FDA's Holiday Gift to Industry: Easy-to-Search Guidance Documents

Christmas came late for the pharmaceutical and medical device industries this year, but the gift was worth the wait. After years of complaints from the public and industry alike, FDA finally unveiled a new, easy-to-search guidance document database combining all the agency's various documents into a single source. Prior to the launch of the database, regulatory professionals would need to hunt through dozens of poorly organized pages on FDA's website in order to find the documents they were looking for.

1.) Regulatory Explainer: The 21st Century Cures Act

Our incredibly thorough explanation of the House Energy and Commerce Committee's 21st Century Cures Act was by far our most popular article of the first quarter. The explainer breaks down the various components of the Act, which is intended to overhaul the way in which the US Food and Drug Administration (FDA) reviews new products, as well as the incentives given to companies in return for developing new products.

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