Have some spare time on your hands? Read the new Final Rule that FDA pre-published today (here) . FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in […]
While there is not much new or trendy in the updated figures, it is clear that OGD is issuing more Complete Response Letters (CRLs). July saw the second highest number of CRLs for FY 2016 with 169 (highest was 190 in April). These numbers are also significantly higher than those in previous years. This means […]
Today, FDA reissued the Guidance for Industry: Abbreviated New Drug Application Submissions-Refuse to Receive for Lack of Justification of Impurity Limits, but the word “Proper” was removed from its title. The title of the previous version read Abbreviated New Drug Application Submissions- -Refuse to Receive for Lack of Proper Justification of Impurity Limits (emphasis added). While […]
Fidaxomicin, like vancomycin, is indicated for treatment of Clostridium difficile-associated diarrhea. Both drugs are poorly absorbed systemically and treat the condition locally in the gut and intestines. Vancomycin, however, appears to be more soluble that fidaxomicin over the range of physiologically-relevant dissolution media. The innovator of fidaxomicin submitted a petition, FDA-2015-P-1595 (here) requesting that […]
For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications. Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, […]
Our blog post of August 15, 2016 contained an error. What we meant to convey was that unless the capsule composition did not change, a PAS was required. We have changed the post to correct this error, and apologize any confusion that this might have caused.
Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be […]
I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by […]
The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here). So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY). OGD did say there would be good and bad months for approvals […]
Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers. Some metrics have only been reported in the same context for the last […]
