H

ello, 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The Food and Drug Administration issued a draft guidance that it called “a first step” in encouraging drug companies to study medicines that might be considered for marketing without a prescription.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. Try it FREE for 30 days!

SUBSCRIBE TODAY

What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

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 Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy