This is the second edition of the “Did You Know?” series featuring some of the lesser known (or at least widely known) aspects of the GDUFA III program changes and the impact on the generic drug industry. Today we will focus on elements of Pre-ANDA Development Program. GDUFA III has opened the door for additional […]
Those of us that have been in the trenches since the passage of Hatch-Waxman have seen the issue of adhesion and sensitization studies for transdermal delivery systems (TDS) change dramatically. Well, there are now two new guidance documents that take us to the next step in recommended adhesion and irritation/sensitizations (I/S) testing revisions. First is […]
The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions. If you have been following the debarment notifications […]
The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]
To follow up on last week’s blog (here). I came across the Amicus Curiae brief filed by the Solicitor General in the Teva v Glaxo case regarding the skinny label provisions of the Hatch-Waxman Act. I thought you would be interested in reading the brief for this important case so here it is! Enjoy the […]
When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full […]
That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may […]
Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here). If passed, the bill would direct the […]
When we reported the unofficial January approval actions in a previous blog post, there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]
The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.” The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]
