Regulatory Trackers


Focus' Regulatory Tracker Series: Keeping a Close Eye on Regulatory Developments

Wondering if new legislation might affect your upcoming medical product? We have you covered. Wondering what advisory committee meetings are on the horizon? We have the details. Want to know more about FDA's actions in a particular area? We're the go-to source for many topics

Read on to discover which Regulatory Trackers we maintain and how they can be useful for you.

Broad Topics

FDA Advisory Committee Calendar
FDA's Advisory Committee meetings represent a life-or-death scenario for many drug products. A favorable vote from a committee, while not binding on FDA, can often signal that a drug is destined for approval. A negative vote, meanwhile, can signal that a drug's chances are doomed.  Keep track of all pharmaceutical and scientific advisory committee meetings in this tracker maintained by Tarius. (Updated weekly)

Finding Information

The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech
Regulatory Focus has assembled a list of the most important FDA webpages, government websites and non-governmental websites, all in the hopes of making FDA-related information easier to find. (Updated semi-regularly)

Using RSS Feeds as a Regulatory Intelligence Tool
How can you find the latest information on the life sciences industry? You could manually go to hundreds—even thousands—of different websites each day. Or, you could set up an RSS Reader using any of the hundreds of RSS feeds in this RSS Feed Tracker. (Updated annually)

Using Twitter as a Regulatory Intelligence Tool
Twitter—it's not just for telling the world what you ate for lunch that day. Keep track of the latest regulatory news, information and intelligence by following some of the industry's smartest people on Twitter. We've collected nearly 500 of the best accounts we think are worth following. (Updated annually)

9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape
Are there any free tools regulatory professionals can use to find regulatory information more easily? There sure are. Check out these nine incredible—and FREE—tools you can use to find the information you need to do your job. (Not updated)

The Essential List of European Pharmaceutical and Device Regulatory Authorities
This essential resource lists all of the state and regional regulatory bodies in Europe, including the European Medicines Agency (EMA) and local pharmaceutical and medical device regulators, as well as the local ministries of health. (Updated annually)

Niche Regulatory Issues

Patient-Focused Drug Development Tracker
Since 2012, FDA has made a concerted effort to start engaging with patients through its Patient-Focused Drug Development Program. The program, required under new legislation, has involved FDA meeting directly with patients to better understand how they assess the risks and benefits of potential treatments. Our tracker looks at each proposed meeting, which questions have been asked of each group of patients and what the outcomes of each meeting have been. (Updated regularly)

India's Data Integrity Problems
Since 2013, the US Food and Drug Administration has seemingly launched a crackdown on India's pharmaceutical manufacturers, issuing more than a dozen warning letters regarding severely deficient manufacturing practices. Those Warning Letters have all mentioned a common deficiency: Data integrity. Find out more about this problem and who's been involved in our data integrity tracker. (Updated regularly)

FDA Drug Advertising Study Tracker
Drug advertising has been a hot topic at FDA for decades. In recent years, however, the agency has quietly begun launching new studies to assess how consumers understand drug ads, how they understand risk, whether some factors are especially influential in drug advertising, and whether some groups of patients are influenced more than others. Find out more about FDA's proposed studies and what they might mean for the future of pharmaceutical advertising. (Updated regularly)