There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]
In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is […]
On Tuesday from 9:00-3:00 PM, the FDA held a virtual public meeting to obtain initial input from federal agencies, healthcare organizations, industry trade associations and other stakeholders in general on the reauthorization preparations for the third iteration of GDUFA. It is not known whether FDA will provide a link to the virtual program, as it […]
Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed. We all understand the history of […]
FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020. The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]
The story started in 1962 with the congressional passage of the Kefauver-Harris Amendments that added efficacy requirements for all new drug approvals. For those products approved for safety only during the period from 1938 to 1962, an evaluation of efficacy of those products was undertaken in the Drug Efficacy Study Implementation (DESI) program. The DESI […]
