The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list. Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug. Now, […]
At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes. He outlined a number of these changes from GDUFA II […]
October is the first month of the fiscal year 2023 and, while not necessarily a bellwether of things to come, it is certainly the starting point of GDUFA III. The unofficial tally looks good as OGD issued 58 full approval actions and 11 tentative approval action for a total of 69 total approval actions. While […]
So, you have just been granted a face-to-face (FTF) meeting with the FDA. Woohoo! You’re going to Bethesda! Don’t be too quick to make those plane and hotel reservations. This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes […]
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 […]
