1. Pink Sheet
  2. >>Product Reviews
  3. >>Post-Marketing Regulation & Studies

Isotretinoin REMS Modifications Show How Advisory Panel Can Push FDA To Change Its Mind

 
• By Sarah Karlin-Smith

US FDA makes five changes to ease burden of risk management program for acne drug – going further than the agency initially seemed comfortable with in March, though not always in line with what the generic sponsors were seeking.

close up of women with acne on her face
Changes to isotretinoin REMS should make access to the acne drug easier. • Source: Shutterstock

The US Food and Drug Administration agreed to five modifications to the isotretinoin Risk Evaluation and Mitigation Strategy including a relaxation of pregnancy test procedures following an advisory panel that stands out as an example of how a committee's input can shift the agency’s thinking.

The iPLEDGE REMS is notable for its restrictive distribution even among other teratogen products and while FDA indicated willingness to relax some of the measures ahead of an advisory panel...

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 Post-Marketing Regulation & Studies

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

More from Product Reviews