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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12
Dec

Revision 1 of Risk information in Promotional Materials and Ads Hits the Street 

Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here).  This Guidance covers the following four topics:  Providing quantitative efficacy or risk information for the control group, when applicable;  Presenting probability information in terms of absolute frequencies, percentages, and relative […]

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29
Nov

That DRESS Could Be Life Threatening! 

The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).  The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]

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22
Nov

A New Wave of Warnings for Pain Relief Products with Hidden Drug Ingredients 

Just like the FDA says on its warnings and notifications page (here):  “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]

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