In a time that we find ourselves so busy, who has time to attend a conference? That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the […]
If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019. The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October. Two big […]
What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant. We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first […]
The Office of Generic Drugs (OGD) posted its official numbers for approval actions, receipts and complete response letters in the last hour. The figures, from the Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) show that OGD broke the old record of 763 approvals achieved in FY 2017 by 18 ANDAs, […]
Today FDA announced finalizations in two guidance documents for transdermal systems (TDS) one relative to skin adhesion studies (here) and one related to skin irritation and sensitization studies (here). The revisions to the previous drafts came after FDA considered a number of industry comments to those drafts. With the finalization of the guidance documents, FDA […]
A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing. During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing. Neither the current guidance ICH Q1A(R2) “Stability Testing of New […]
OGD updated its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) on Wednesday, giving us a look at some additional metrics for the month of August. For all the talk of Refuse-to-Receive (RTR) actions, OGD issued only seven (7) in August. Four (4) were for standard ANDAs and three (3) were for […]
Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals. We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but […]
On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA). The FDA presented to the Advisory Committee two primary goals of the KASA program. On the one hand, it is intended […]
The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format” (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents. There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix […]
