14
Aug
Police Officer Making Traffic Stop

Do You Have Your Checkbook Ready? Be sure Clinicaltrials.gov Listings Are Made and Are Accurate!

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 […]

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13
Aug
Starting block athletes

Are You Ready? Because the FDA IS Getting Ready!

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?  […]

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29
Jul
ruler

OGD Quarterly Activities Report – Look What’s Going On!

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 […]

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22
Jul
Male hand holding megaphone with it s time to start speech bubble. Loudspeaker. Banner for business, marketing and advertising. Vector illustration.

Virtual Public Meeting Generic Drug User Fee Amendments – A Perspective for GDUFA III

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 […]

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20
Jul
Hooray

Proposed Law Would Provide pathway for Generic Drugs Labeling Changes with a Reasoned Approach

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 […]

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10
Jul
Wolf howling to the moon

Domestic Priority Inspections to Restart on July 20 – With Conditions

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 […]

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10
Jul
RIP Headstone

PETN Dead for Good After Final DESI Hearing Decision and Exceptions Are Deemed Withdrawn

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 […]

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