The Pharma Data
MARCH 15, 2022
To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.
XTalks
JUNE 8, 2022
Sandoz is a pioneering leader in generic pharmaceuticals and biosimilars, as Sandoz launched the world’s first biosimilar in Europe in 2006 and won the first biosimilar approval in the US in 2014. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.
FDA Law Blog
OCTOBER 29, 2023
This guidance was based on stakeholder feedback that the current FDA Birth Control Guide may not identify all and/or newer contraceptive products approved, cleared, or granted by FDA.
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