For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date. On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products […]
As the pace of accelerated approvals has increased over the past few years, and as the number of withdrawals of accelerated approvals for some indications and products has also increased, the latest FDA move to seek removal of Makena, the premature birth preventative, for lack of efficacy could spell trouble for firms that cannot demonstrate […]
This is the first month of GDUFA III and thus the first month of FY 2023! For approval actions posting through October 19th which include approvals posting through October 17th (postings are usually one or two days behind the actions taken), OGD has issued 22 full approval actions and 6 tentative approval actions for a […]
A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]
Anyone who has been involved in basic science knows that the ultimate goal is publication of your research in a peer reviewed journal. If you work in discovery in a firm, the goal is the same, and the company looks to commercialize promising leads as potential therapeutics. We are happy to announce that one of […]
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 […]
