2004 Biosimilars Labelling 
FDA Law Blog: Biosimilars
JANUARY 12, 2025
Moreover, an application (NDA or BLA) based upon a surrogate or intermediate clinical endpoint seeking accelerated approval must still meet the substantial evidence of effectiveness standard and contain sufficient information to demonstrate that the drug is safe for use under the conditions of the proposed labeling.
FDA Law Blog: Biosimilars
MAY 23, 2023
Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.
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European Pharmaceutical Review
DECEMBER 20, 2023
Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) By contrast, orphan drugs could become less profitable, more risky investments.
European Pharmaceutical Review
JULY 4, 2024
However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 10 Directive 2004/24/EC introduced a registration scheme for traditional herbal medicines and requires herbal remedies sold over the counter in the UK to be registered. 2012/1916).
FDA Law Blog: Biosimilars
AUGUST 4, 2023
Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.
BioPharma Dive
JULY 22, 2025
billion since its inception in 2004 and, since then, its portfolio companies have been involved in 47 initial public offerings and 50 acquisitions, among them the recent buyouts of Scorpion Therapeutics and Morphic Therapeutic , the firm said. — Omega has raised more than $2.5
PharmaShots
APRIL 13, 2023
in the year 2004, depicting a growth of 17% from 2003 with cost savings and synergies from the prior acquisition of Pharmacia. Following its patent expiry, Cipro’s sales in the year 2004 declined by 12.9% Bayer’s Matetial Science subgroup moved ahead effectively in 2004 showing a rise of 15.3%
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