FDA Law Blog: Biosimilars
AUGUST 14, 2023
Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B.
Pharmacy Joe
JANUARY 17, 2021
In this episode, I’ll discuss novel dosage forms that should not be crushed but look like they can be. Episode 575: Novel dosage forms that should not be crushed (but look like they can be) Subscribe on iTunes , Android , or Stitcher Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions.
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European Pharmaceutical Review
JULY 10, 2023
The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes.
European Pharmaceutical Review
NOVEMBER 11, 2022
Developments need to be made to enable lower dosages and toxicity, limit adverse effects and find better treatment efficacy of ocular drugs, it stated. A key challenge discussed is active pharmaceutical ingredient (API) impurity profiling in finished dosage forms. The paper by Asendrych-Wicik et. analogues to treat glaucoma.
European Pharmaceutical Review
AUGUST 25, 2022
The investigation was launched after NDMA and NDEA were detected in a finished dosage form, though neither were identified in the bulk drug product. With blister packaging among the most commonly used packaging type for pharmaceutical products worldwide, the findings could have significant implications for industry.
Pharmaceutical Technology
MAY 19, 2023
In a January presentation, the company shared that approvals in additional indications would allow Rinvoq and Skyrizi, a monoclonal antibody, to gain peak share in the different markets, including inflammatory bowel disease. In patients with severe symptoms, a dosage of 30mg can be considered.
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”
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