Biosimilars

10
Nov

A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.

Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]

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30
Oct

EU Issues Communication Addressing Medicine/Drug Shortages 

The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem.  The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here).  This is a deep dive […]

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24
Oct

Dissemination of Articles and Study Results, New Revised Q&A Draft Guide May Provide Better Direction

Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]

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08
Oct

Signs of Progress on the Nitrosamine Front – Notes from the Nitrosamines Session at GRx+Biosims 2023 

The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator!  It was even more difficult than usual […]

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05
Oct

The State of Biosimilars and Generics 2023

The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research.  I just could not think of a better title!  It is like the State of the Union address but not as expansive.  Dr. Corrigan-Curay spoke to the […]

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05
Oct

GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections

On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry.  Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon.  Dr. Downey opened […]

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04
Oct

Chipping Away at 180-day Exclusivity:  A Good Discussion 

In a rousing session at the AAM’s GRx-Biosims conference, Kurt Karst, J.D., Director, Hyman, Phelps & McNamara, Brian McCormick, J.D., M.H.S., Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals, and Chad Landmon, J.D., Partner, Axinn, Veltrop & Harkrider LLP gave a presentation entitled 180-Day Exclusivity: What Is Past Is Prologue or, as they like to […]

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27
Sep

Mullin and Booker Introduce Bill for e-labeling – New Round Begins

Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously.  There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]

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