Hello, everyone, and how are you today? Despite the mounting heat enveloping the Pharmalot campus, we are doing just fine, thank you. We actually stay cool by quaffing hot cups of stimulation. We do not have scientific evidence to support out behavior, but the tactic, nonetheless, is successful. So feel free to join us. Meanwhile, we have gathered another bushel of items of interest to help you get started. As always, we hope your journey today is successful and you conquer the world …

The Food and Drug Administration issued a draft guidance that it called “a first step” in encouraging drug companies to study medicines that might be considered for marketing without a prescription. The guidance outlines two approaches for demonstrating safety and effectiveness that may be useful to consider in cases where the product labeling alone is not sufficient to ensure the drug can be used safely and effectively in a nonprescription setting. The first is the development of additional labeling and the second is using technology so consumers can make decisions.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • To springboard off the last item above to reply to our scribe’s first comments of the day, as they say on the sub-continent: “Drink hot when it’s hot ….” That is a sufficient anecdotal/ cultural basis for ‘your habit.’ Drink up!

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy