After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs. The advance publication notice in the Federal Register can be found (here). The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or […]
Dr. Kathleen (Cook) Uhl said there would be good months and not-so-good months. Well, although the official numbers for November are not yet posted, it looks like OGD will have another good month. Not a record breaker, but close, unless there are at least 4 more not yet reported approval actions lurking somewhere in the […]
The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings. As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose […]
While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process. It seems that we are not alone! In remarks made at the November 27th FDA […]
With 5 business days and 6 reporting days until December 1st, OGD already has booked 79 full approval and 23 tentative approval for a total of 102 approval actions so far in November. This could be good news, as a trend towards more record numbers of approvals is now evident. We have had two consecutive […]
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 […]
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 […]
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 […]
