FDA’s User Fee Staff provided an overview of the progress and implementation of the first year of GDUFA II and BsUFA II user fees during the afternoon session of the second day of the GRx +Biosims Conference held at Baltimore, MD from September 5-7. The presentation recapped how the user fee structure for GDUFA II […]
On the second day of the first annual 2018 GRx+Biosims Meeting in Baltimore, MD held from September 5-7, 2018, Kurt Karst, JD and Mark Schwartz, JD (Directors, Hyman, Phelps & McNamara, P.C) provided a very informative overview of cGMP trends and emerging legal issues concerning GDUFA and FDARA. The on-going modernization of the generic drug […]
In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm). The Center for Drug Evaluation and Research (CDER) issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1, Understanding CDER’s […]
The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations. One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER. It had to do with data integrity. Dr. Barkow noted, “about 40% of […]
Historically, the Office of Generic Drugs (OGD) has classified major/minor amendments on the time necessary for review. Minor amendments required minimal review, while major amendments required extensive review. If there was an issue with a facility (e.g., cGMP), the old Deficiency Letters (DLs) and Complete Response Letters (CRLs) used to state that the firm should […]
According to our best calculations and current data on the FDA “All Approvals” page (here), it appears OGD has approved forty-seven ANDAs and tentatively approved eleven ANDAs in the month of August. These numbers are far below the record breaking ninety-six full and thirty tentative approvals seen in the month of July. This is not […]
As we know July was a record breaking month for approvals as reported here, but it was also a record shattering month for Complete Response Letters, beating the October 2017 previous total of 325 with a whopping 357 CRLs. This may be a little disturbing as the trend in FY 2018 is for an overall […]
I just searched through 643 hits on Regulations.gov for 505(j)(2)(C) petitions. Granted, all of those were not actually for ANDA suitability petitions under the citation listed above, but most were. The good news is that the industry still submits these petitions (an ANDA suitability petition requests a change from a reference listed drug in strength, […]
The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018. Sponsors should expect to receive their invoices by August 29, 2018. This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15, […]
In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason. Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare […]
