FDA Law Blog: Biosimilars
APRIL 16, 2024
To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,
FDA Law Blog: Biosimilars
APRIL 3, 2023
In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.
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FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.” FDA borrowed this definition from 21 C.F.R. mg) and the concentration (e.g.,
European Pharmaceutical Review
MARCH 1, 2023
X-ray technology is also increasingly used in pharmaceutical R&D, particularly for examining solid dosage forms, an application for which this technology can be seamlessly adopted. He currently works as a Chief Scientific Officer at GILYOS GmbH, a CRO for freeze-dried products, which he founded in 2010. Hancock BC, Mullarney MP.
RX Note
APRIL 3, 2024
If response to a prostaglandin analogue is poor, switching to another one may be effective as drugs in this class are structurally different.
Pharmaceutical Technology
OCTOBER 25, 2022
Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.
RX Note
JUNE 12, 2023
Dosing in Hypothyroidism The dosage of levothyroxine is individualized based on clinical response and serum thyroid stimulating hormone (TSH) and/or free T4 concentrations. Individual T4 requirements correlate better with lean body weight than total body weight.
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