Axiona Solutions

Make sure the quality of your future eCTD ANDAs to avert a possible loss of any GDUFA goal date

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet? | Lachman... Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet? By Bob Po***ck | March 14, 2016 | FDA, Generics, Regulatory Affairs | 3 | The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Res…

World’s 10 Best Pharma and Biotech Companies of 2015

10 World’s Best Pharma and Biotech Companies of 2015 With $16.3 billion in profits, $131 billion in assets, and $276 billion in market value, Johnson & Johnson takes the crown as the world’s largest drug and biotech company again this year, edgin…

FDA approved ruxolitinib (Jakafi, Incyte Corporation) for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (HU). December 4, 2014. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425732.htm

The guidance describes how a prospective ANDA applicant can obtain a letter stating that FDA has determined:

- prospective ANDA applicant’s bioequivalence study protocol contains safety protections comparable to those in the REMS for the reference listed drug, and

- FDA will not consider it a violation of the REMS for the reference listed drug holder to provide a sufficient quantity of the reference listed drug to the prospective ANDA sponsor or its agent to allow the company to perform the testing necessary to support its ANDA.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425662.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

www.fda.gov