28
Sep
Youth League Batter

Watch the Inventory of CRLs in Your Court – Don’t be Blindsided, Be Mindful

Did you ever wonder about the FDA’s requirement than an applicant respond to a complete response letter (CRL) within one year of its issuance as provided for in the regulations at 21 CFR 314.110?  Under this regulation, “an applicant must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified […]

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17
Sep
Surprised employer holding long resume, amazed with impressive career achievements

Official August 2020 Approvals and Receipts for ANDAs Reported

The Office of Generic Drugs (OGD) reported some of its official statistics for August today.  As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]

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02
Sep
Bumpy Road

Is the Orange Book Patent Listing Process becoming “Divisive”?

The Drug Price Competition and Patent Term Restoration Act of 1984 (better know as Hatch-Waxman) provided a balance between innovation and competition by permitting generic drugs to rely on the safety and efficacy of a previously approved reference listed drug (RLD) rather than unnecessarily repeating duplicative clinical testing to prove what was already known about […]

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01
Sep
Slippery Slope road sign in front of cloudy sky background

EUA for Vaccine – Slippery Slope or a Shot in the Dark

The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests.  By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]

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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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