Labopharm seeking FDA dispute resolution

Share this article:
Labopharm says it is seeking formal FDA dispute resolution proceedings to counter an approvable letter from the agency requiring undisclosed additional work on its NDA for a once-daily formulation of the pain-reliever tramadol.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Legal/Regulatory

Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.