FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.
The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018. In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,
With eCTD submission format becomming binding as of May 5, 2017 for NDA, BLA, and ANDA and May 5, 2018 for Commercial IND and Master Files, the number of submissions to the FDA in eCTD format has significantly increased. According to Jonathan Resnick of the Office of Business Informatics (OBI), CDER received nearly 180,000 eCTD submissions in 2017.
Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines. Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part of a larger strategy for electronic regulatory submission and review at the FDA.
Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program. The proposals (here) include regulatory and review process changes, as well as organizational restructuring. The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development.
A number of years ago, I was reading a blog by Kurt Karst (here), the title of which included “A 505(b)(2) NDA in Search of a Basis for Submission and Approval…” Apart from the interesting details covered in the blog about how a product was received under the 505(b)(2) pathway, it highlighted a trend that was in the making.
The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals. While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals.
Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA. It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda,
Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right. At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter,