15
Feb

OGD Provides Update to Future Product Specific Guidances as Well as Planned Revisions 

Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections:  Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Section 1 contains a list […]

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13
Feb

OGD Publishes Its Official December FY2024 Statistical Report 

Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions.  Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received.  The OGD officially issued 53 approval actions in […]

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09
Feb

AAM Annual Meeting: CDER Discusses Biologics and CEOs React 

At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals.  The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals.  Here are some of the points […]

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09
Feb

Doug Long Receives Lifetime Achievement Award at AAM Annual Meeting After Presentation

Doug Long has become a fixture at AAM meetings, providing invaluable data on the drug industry on behalf of his employer, IQVIA.  This presentation is always the highlight of AAM annual meetings.  All attendees at this meeting make sure to have their seats nice and early to hear his state of the generic and biosimilars […]

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01
Feb

FDA Publishes Medical Devices Quality System Regulation Amendments Final Rule 

The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule.  The FDA states:  “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes.  […]

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31
Jan

FDA Warns About Yet Another “Fake” Set of Eye Drop Products

Today, the FDA is warning consumers of potentially contaminated copycat eye drops that are unapproved new drugs that “copy the Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.” While the FDA notes that it has not received any specific reports of adverse events with the three products named below, […]

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16
Jan
Headline shortages

Just When You Thought the Lisdexamfetamine Shortage Was Over, the Capsule Product Takes Another Hit 

Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs (here) that we believed would mitigate the ongoing shortage.  Today, however, the FDA reported (here) that Lisdexamfetamine capsule dosage-form products are in trouble again.  On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of […]

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03
Jan

New End of FY 2023 Posting by OGD Takes Some Time to Figure Out

The FDA published the Generic Drugs Program 2023 Fiscal Year Web Posting (here) on December 28, 2023.  This document reflects the FDA’s performance for meeting GDUFA goal dates for FY 2023 submissions.  The document meets the required reporting of certain performance metrics as outlined in the GDUFA III commitment letter. Bravo to the OGD for getting the report […]

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