05
Mar
Mothers of preschoolers

FDA Updates January 2021 Statistics – Are Both the Industry and FDA Experiencing a Slowdown?

The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics.  As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]

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05
Mar
Vials

Vial and Component Relief from the FDA for the Vile component Shortage Created by the Pandemic

FDA has proposed some relief from the component shortages created for parenteral and other products identified in the just released Guidance entitled, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. The Agency has recognized the need to provide some regulatory flexibility regarding the filing type for certain changes that may be necessitated […]

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03
Mar
Businessman Looking At The End Of The Road

FDA Determination that Lorcaserin Was Withdrawn for Safety Reasons

On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer.  On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]

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02
Mar

After Two FDRR, FDA Set to Issue Refusal to Approve NDA for Sotagliflozin Oral Tablets

In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg.  The product was intended to be indicated […]

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24
Feb
Corona Virus covid-19 illustration

Staying Ahead of SARS-CoV-2 Variants as You Develop Your Monoclonal Antibody Products

As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals.  Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population.  The good news is that the FDA […]

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19
Feb
Female Chief Analyst Holds Meeting Presentation for a Team of Economists. She Shows Digital Interactive Whiteboard with Growth Analysis, Charts, Statistics and Data. People Work in Creative Office.

Official Approval Action Numbers and More for January and Update of December 2020 Stats

OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020.  From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]

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11
Feb

LACHMAN’S MEDICAL DEVICE WEEK REVISITED

Medical Device Week, a Lachman Learning Experience™ provided a great opportunity for industry professionals to gain knowledge and insight into a range of topics critical to the medical device industry. Our initial feedback indicates that those who participated found it valuable and highly informative. One of the most important topics covered was the FDA’s focus […]

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04
Feb

Don’t Reinvent the Wheel – Use Your SDLC Infrastructure to Manage Product Change Control

What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA?  I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]

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02
Feb

No New FDA FR Notices Since the Inauguration!

We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021.  Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]

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