11
Nov
Quality Agreements Image

FDA Gives Some Updates and Some Advice at AAM GRx+Biosims Conference

Day two of the Association of Accessible Medicine (AAM) Generics and Biosimilars Conference, which took place on November 8, 2022, started with plenary session presentations from Dr. Susan Rosencrance, Acting Director, Office of Generic Drugs (OGD), Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ), and Donald Ashley, JD, Director, Office of Compliance (OC) with the FDA. […]

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20
Sep

Remote Non-Inspection “Inspections”

Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions.  This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch […]

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19
Apr
Continuous Manufacturing and its Regulatory Challenge Image

Particles, Particles, Particles – Some Have a Game Plan

During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.”  Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.”  She discussed product loss resulting from five-micron […]

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06
Apr

Some Interesting Takeaways from PDA Meeting Day 1

The theme for the PDA annual meeting this year is “Agility in the New Normal.”  The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.”  He spoke about the intrinsic […]

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01
Feb

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference.  This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]

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05
Feb

Safety Trial Finds Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)

When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]

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