The Lachman Blog

17
Jun

Halfway Through June 2021, Approval Actions Appear to Hit Sub-Par Numbers

We have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions.  Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]

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14
Jun

Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic […]

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11
Jun
Sockeye Salmon Jumping Up Falls

Between a Rock and a Hard Place – Accelerated Approval for Alzheimer’s Drug Brings Cheers and Jeers!

Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease.  One member said, when he resigned, that “this is the worst decision the FDA has ever made.”  I get it.  When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]

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10
Jun

OGD Provides Updates to the April 2021 Statistical Report

The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]

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03
Jun

FDA Publishes Four Guidances on Supply Chain Security Issues

The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]

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02
Jun

Don’t Get a Swelled Head, Feeding Tube Guidance Straightens Out Requirements

Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons:  swelling of […]

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27
May

Is This the Beginning of Withdrawal of the Withdrawal of the Unapproved Drug Initiative?

In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]

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