03
May

Is the New Proposed Legislation (S-1462) Regarding ANDA Suitability Petitions as Good as it Sounds?

The ANDA suitability petition process has been languishing for years.  Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition.  Today, I read […]

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30
Apr

Minutes, Minutes, Minutes – Smallest Program Has the Most Transparent Discussions

Do you ever wonder why the minutes of the PDUFA and GDUFA user-fee negotiation sessions are so scant?  Minutes of one-hour meetings with the drug companies are typically two to five pages at the least, depending on the topics discussed. Transparency for the drug UFA negotiation meetings appears to be somewhat lacking (see previous post […]

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30
Apr
Quality Agreements Image

Important ISPE Meeting on Quality Risk Management Sustainability

On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management.  Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]

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21
Apr
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

Second Quarterly Activities Report of the Generic Drugs Program FY 2021 Released

The FDA released its Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the second quarter of FY 2021 late yesterday.  And there were not any real surprises. Y2021 First Quarter October – December Second Quarter January – March Third Quarter April – June Fourth quarter July – September ANDAs awaiting […]

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20
Apr

OGD Provides Official Stats for Approval Actions for March 2021 and More

As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post.  Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]

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12
Apr

OGD Updates February Statistics

OGD updated and provided the remainder of its monthly metrics for February 2021 in its Generic Drugs Program Activities Report – Monthly Performance (here).  Here are some interesting observations! OGD issued 7 refuse-to-receive (RTR) actions which is the most since January 2020 when they also issued 7 RTR actions.  All were for standard ANDA applications. […]

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12
Apr

Examples of Many of the Catch 22s of Controlled Correspondence with the FDA

Okay, so you want to bring a product back from the dead.  That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB).  Oh yeah, and you also want to start a development […]

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08
Apr

False Negative COVID-19 Tests Further Complicated by Variants

The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results.  The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]

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