As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”. The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news. First, the number of ANDA awaiting FDA action […]
Last Friday, FDA issued four (4) guidance documents that establish the FDA’s current thinking on requirements for establishing sameness and bioequivalence of topical products. They cover in vitro permeation testing, in vitro release studies, Q3 characterization studies, and studies required for corticosteroids of medium and high potency. While there have been many documents and discussions […]
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 […]
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 […]
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 […]
Congressman A. Donald McEachin (VA-04) comments “Today, [I] introduced the Updated Drug Labeling for Patient Safety Act, legislation to direct the Food and Drug Administration (FDA) to allow generic drug manufacturers to update their product labeling with safety-related information.” (see here). He notes that “[T]he Updated Drug Labeling for Patient Safety Act is commonsense legislation […]
All indications seem to be that all the User Fee reauthorizations (loving known as the UFAs) will be passed in a fairly clean bill by the end of the week. This is great news for FDA employees and for industry; however, we sure hope that they tell us what to do as that will basically […]
According to Zachary Brennan’s story on Endpoints (here), Sally Choe will be leaving OGD in two weeks coinciding with the end of GDUFA II and the beginning of GDUFA III. The interim Director will be Susan Rosencrance “who’s currently director of the FDA’s Office of Lifecycle Products in the Office of Pharmaceutical Quality and has […]
