FDA Draft Guidance on Acyclovir Enables DiTEBA’s Novel IV Approach to Achieve Biowaiver Status, Replacing Clinical Trials
March 30, 2017
DiTEBA is pleased to announce it has developed a novel in vitro approach to qualify acyclovir cream products for biowaiver status in accordance with the recently released FDA draft guidance on acyclovir.
May 25, 2016
Do you know what is required to ensure FDA/regulatory compliance for your submission? Download our comprehensive IVRT/IVPT E-Book to gain an in-depth knowledge of this increasingly required, but often challenging, testing method for semisolid drugs.
CROs are increasing their IVRT capacity as FDA emphasizes its use for topical/transdermal drug submissions
October 21, 2015
For a number of reasons, from issues with oral dosage first-pass metabolism of the liver, the acidic environment of the gastrointestinal tract, and problems of absorption in the stomach, to an aging population who have a hard time swallowing pills orally (pediatric patients also fall into this category), the clinical need for alternatives to oral solid dosage delivery has never been greater.
DiTEBA Registered as Drug Establishment with U.S. FDA
July 21, 2014
NDI ADRL Inc. dba DiTEBA, Nutrasource's analytical and testing facility, is pleased to announce that its registration with the U.S. FDA has been seamlessly transitioned to the new corporate name.
It is now registered with the FDA in accordance with Section 510 (i) of the Food, Drug and Cosmetic Act and 21 CRF 207.40 as Drug Establishment (Registration No. 3005415167). DiTEBA has been registered with FDA since 2005.