The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory. The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the […]
In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason. Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare […]
The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions. The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging. The FDA has always said that for most complex drug device products, the product […]
Well, after a couple of comments on my post (here) regarding timelines for resubmissions of MDAs, BLAs, and efficacy supplements, it came to my attention that this was an older MaPP. Sorry for the confusion but it came up as new on a daily feed I routinely review for blog material. Anyway, it certainly is […]
The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today. The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues. The document identifies resubmissions to NDAs, BLAs, and efficacy supplements […]
The official numbers of approvals and receipts are out for May 2018. OGD fully approved 67 ANDAs (one more than last month) and tentatively approved 19 ANDAs (which was six more that we found prior to the final posting) for a total of 86 approval actions. Given these numbers, if we straight-line the approvals for […]
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
Today, the FDA released its second revision to its “Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level”. The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides additional clarification as to what matters are not appropriate for Formal Dispute Resolution Requests (FDRRs).
