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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20
Nov

New Draft FDA Guidance on BLAs for Biosimilars and Interchangeable Biologics

The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products.  This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]

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04
Aug

Pharma’s Fight Against the Coronavirus Pandemic

A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19. Contract Pharma recently published an article authored by Keith O. Webber, Lachman Consultants. He says, “Although we are faced with significant challenges, hopefully the recently published guidance documents from the FDA in conjunction with the […]

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21
Feb
Colored skittles with different sizes

Less is More!

Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA).  Specifically, the […]

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14
Feb
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

  January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

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11
Feb
A man is completing the construction of a bridge. Build bridges, make connections and useful contacts. Improving and developing a business. New innovative solutions, growth and prosperity

FDA Provides Valuable Guidance on Bridge-Building for Combination Products

Three of FDA’s Centers (CDER, CBER, and CDRH) recently published a combined draft guidance for Industry entitled Bridging for Drug-Device and Biologic-Device Combination Products  (here).  This draft guidance provides the FDA’s current thinking on what manufacturers should consider when they wish to bridge the data from one such combination product to another combination product during […]

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05
Feb
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FDA and FTC Announce a Coordinated Plan for Advancing Competition in the Biologic Drug Marketplace

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market.  This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products.  A significant focus […]

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10
Dec
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Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

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 […]

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