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 […]
In FDA’s just released report, Estimating Cost Savings from Generic Drug Approvals In 2017, the Agency points to some staggering savings to consumers from the generic drug applications it has approved. I have read through the report a number of times already, and must say I am not quite certain what the numbers actually mean, […]
OGD just updated its April 2018 statistics as it does before it reports the next month’s receipts and approvals. You can see all of the updated figures for April here, but there are a few things we think are noteworthy to point out. OGD only refused-to-receive (RTR) five (5) ANDAs in April, which was the lowest […]
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 […]
The FDA has released its required annual report on 505(q) petitions. Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act. Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has […]
