16
Sep

Weight Loss Drug Voluntarily Withdrawn for Apparent Safety Reasons

The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively.  This announcement was made on the Federal Register’s […]

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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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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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10
Aug

What Were These People Thinking?

A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.”  Basically, the press release goes on to describe fraudulent activities relative to the […]

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29
Jul

Repackaging Product into Unit Dose Packaging and Stability Requirements – Final Guidance Issued

Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies.  The Agency notes that it “received a few comments on the revised draft […]

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14
Jul

More DESI Drugs Bite the Dust as Final FDA Decisions Delivered in DESI Clean Up Action

Two prepublication Federal Register (FR) notices provide the backdrop for the historical demise of several products, and, with the final decision being affirmed that the products lack substantial evidence of effectiveness, they may no longer be marketed unless a New Drug Application with clinical data supporting the indications is submitted and approved. Vasodilan injection and […]

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29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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