Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.
While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here) on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2. OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!
The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here). The notice states that:
Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.
Although the Office of Generic Drugs (OGD) has not yet released the official approval numbers for October 2018 (which is the first month of FY 2019, and the first month of GDUFA II), it appears that a new record will be set. OGD approved 101 ANDAs, and tentatively approved 21 ANDAs for a total of 122 approval actions for the month;
Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here. There are some interesting figures and comparisons to previous years that are discussed below.
Let’s look at refuse-to-receive (RTR) actions to start. FY 2018 saw the fewest RTRs since the start of GDUFA.
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 presence of key FDA regulators.
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 days so far this month were October 12th,
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 approved applicant for potassium chloride actually notified the FDA of its commercial marketing through the FDA’s electronic gateway) but the time window is really not relevant,
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.
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 Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.
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 priority ANDAs.
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 as it stands now,
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 to make the review of the CMC section of NDAs,
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 A of the document.