Regulatory Affairs

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 […]

Read More
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 […]

Read More
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FDA Determination that Lorcaserin Was Withdrawn for Safety Reasons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 […]

Read More
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 […]

Read More
25
Feb

Damned If You Do and Damned If You Don’t – Thinking About a New Permanent Commissioner

There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job.  Not sure why there is so much hype and concern.  Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]

Read More
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 […]

Read More
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 […]

Read More
12
Feb

Skinny Label Reprieve, But Not Out of the Woods Yet!

The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label.  Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case.  Clearly, Congressional intent and regulatory […]

Read More
1 2 118