FDA Approval Licensing Packaging Production 
Pharmacy Checkers
OCTOBER 11, 2019
It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Drug companies make their products in many countries and ship those same drugs around the world to different markets.
FDA Law Blog
DECEMBER 7, 2022
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
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Pharmacy Checkers
JANUARY 10, 2020
This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.
Pharmacy Checkers
MARCH 11, 2020
The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. Recommendations to the FDA for adhering to Section 804 J(1). counterparts.
XTalks
AUGUST 2, 2023
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.
Advarra
JULY 19, 2022
Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?
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