1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA Floats Broader Pathway For Nicotine Replacement Therapies

 
• By Malcolm Spicer

FDA’s report to Congress on tobacco abstinence therapy points toward a “comprehensive strategy” for tobacco and nicotine product regulation, incorporating the work of the drug, device and tobacco centers. Some smoking cessation experts say changes are overdue.

FDA drug, device and tobacco centers plan to collaborate more closely to develop indications other than smoking cessation for nicotine replacement therapies and allow modified risk labeling for tobacco products.

The agency’s recent report to Congress on innovations in tobacco abstinence therapy states that the agency is considering a “comprehensive strategy” for tobacco and nicotine product regulation that would incorporate...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.