With the coming of GDUFA III, many guidance documents have been changed, and new guidances have been released to address new issues under GDUFA III. We have published posts describing many of the changes and now the FDA has issued an updated guidance on prior approval supplements (PAS) (here). The above‑cited guidance replaces the October 2017 guidance of […]
The CDER has issued a final guidance titled Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (here), addressing the role of comparability protocols (CPs) for post-approval changes to the CMC sections of NDAs, ANDAs, and BLAs where the CP is a prospectively written plan for […]
Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years. But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete […]
The PDA Quality & Regulations Conference was held on October 5 and 6, 2022 in Amsterdam; it was healthily attended by a variety of multi-national pharma manufacturers as well as representatives of regulatory bodies from multiple EU countries as well as the USFDA. The agenda was very much data‑driven as presenters focused on how data […]
There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA. Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]
Just after we posted the blog about the other User Fee programs from the prepublication of the Federal Register, we receive an email from FDA indicating that the Fee Schedule was available, but there was a problem with the FR publication (here). Here are the new FY 2023 Generic Drug User Fees compared with the […]
As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.” This certainly applies for GDUFA III and in spades. Why? Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]
With only the September metrics left to round out the FY 2022 statistical report for the OGD, let’s take a look at the full official numbers for August. We also now have a good idea how FY 2022 will stack up against FY 2021, albeit a lot can happen in a few weeks as we await the […]
Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry. The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’ This was the most significant change in this revision. So the question is, can you always average? If […]
The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop. The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]
