Keith Webber, Author at Lachman Consultant Services, Inc.

Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

By Keith Webber Dec 10, 2019 Compliance FDA Quality Regulatory Affairs Science & Technology

The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD. The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”. The conference opened with excellent keynote presentation from Janet Woodcock (Director […]

Nov

The Complexity of Complex – Explained at Least in Part

By Keith Webber Nov 11, 2019 ANDAs Complex Generics FDA Regulatory Affairs

On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products. The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the […]

Nov

Global Regulatory Harmonization for Biosimilars

By Keith Webber Nov 06, 2019 Biosimilars BLA FDA Regulatory Affairs

The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success. This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products. On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) […]

Aug

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

By Keith Webber Aug 27, 2019 ANDAs Biologics BLA FDA Generics NDA

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]

Jul

ICH Q12 – Ready or Not, Here it Comes!

By Keith Webber Jul 30, 2019 Biologics CBER CDER CMC FDA ICH

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum). This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and […]

Jul

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

By Keith Webber Jul 18, 2019 Biologics FDA NDA Regulatory Affairs

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective. Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 […]

Jun

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

By Keith Webber Jun 28, 2019 Biologics BLA FDA NDA Regulatory Affairs

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA). In December of last year, the FDA published a final guidance as […]

May

The Treasure Map to Biosimilarity Just Got More Granular

By Keith Webber May 24, 2019 Biosimilars BLA FDA Regulatory Affairs Science & Technology

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced. The increased level of detail and wider breadth of topics gives a […]

May

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

By Keith Webber May 13, 2019 Biologics BLA FDA Regulatory Affairs

On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product. We did a general post here and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful […]

Mar

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

By Keith Webber Mar 11, 2019 Biologics FDA NDA Regulatory Affairs

On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>. Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products. This […]

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Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

The Complexity of Complex – Explained at Least in Part

Global Regulatory Harmonization for Biosimilars

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

ICH Q12 – Ready or Not, Here it Comes!

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

The Treasure Map to Biosimilarity Just Got More Granular

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

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