STAT
NOVEMBER 30, 2023
Consequently, such “LDTs” can be quickly brought to market without the FDA review of their effectiveness, labeling accuracy, and marketing claims required for regular tests. Read the rest…
FDA Law Blog: Biosimilars
MAY 11, 2023
GSK skinny label case , the U.S. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.”
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Safe Biologics
MARCH 30, 2023
The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature: One significant challenge to efficient global cooperation is the lack of harmonization.
STAT
OCTOBER 26, 2022
But in the field of addiction medicine, the question presents something of a crisis. Even as drugs and alcohol claim 200,000 lives each year, many who seek addiction treatment are greeted by the harsh, stigmatizing labels that many Americans don’t think twice about: Words like addict, alcoholic, junkie, abuser, or worse.
FDA Law Blog: Biosimilars
AUGUST 21, 2023
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.
PharmaShots
APRIL 20, 2023
treatment interruption/discontinuation due to low lgG & lgM in (0.2% & 10.3%)/ (0.2% & 3.6%) patients Ref: Novartis | Image: Novartis Related News:- Novartis Presents Results of Kesimpta (ofatumumab) in P-III (ASCLEPIOS I/II) and (ALITHIOS) Open-Label Extension Trial for RMS at EAN 2022 vs switch group (-0.42%/yr.)
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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