FDA Adds New and Revised Bioequivalence Guidances

The FDA today announced the addition of 21 new and 16 revisions to existing bioequivalence guidance documents.  The Agency continues try to keep ahead of the curve relative to the timing of the issuance of guidance but, at the same time, is making pronouncements for some very old products as well.

For instance, the Agency has issued a guidance for chlordiazepoxide hydrochloride and clindinium bromide (remember the old Librax that for the longest time FDA thought and said it was an unapproved drug? Not anymore!); now there may be an approved generic version at some time in the future.  There were also guidance documents issued for hydrocortisone cream 2.5% which will permit a waiver of in vivo bioequivalence requirements if the physicochemical requirements are comparable to the RLD (interestingly, no requirement for the product to be Q1 and Q2 to the RLD), and another old standard, nystatin and triamcinolone acetonide cream, also only required to have the comparative physicochemical characteristics.

As noted in previous posts, check the revised BE requirements closely as if you have a product in development or pending at the Agency where you relied on previous iterations of a draft guidance, as you may have to perform some additional in vivo or in vitro work to secure approval of your product.  Good luck out there as the target you are trying to hit may be moving before your very eyes.

For a full listing of new BE guidance and updated documents, click here.