FDA Issues Revised Guidance on Marketed Unapproved Drugs
On September 19th, 2011 the FDA announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs-- Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100). This revised guidance clarifies that any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.
Custopharm can assist with filing ANDA's and NDA's. We filed the 1st eCTD ANDA in 2004, have filed over 100 ANDA's since, approved for the Electronic Submission Gateway (ESG) in 2008, responded to over 100 deficiencies in 2010. Custopharm will make you feel comfortable knowing that your submission is of the highest quality.
Custopharm can also assist with Drug Listings, Establishment Registrations, and SPL filings.
Best,
Dave McCleary
dmccleary@custopharm.com