2005 Biosimilars Labelling 
RX Note
DECEMBER 25, 2024
Off label use information can be found here too. However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. Summary During university years, we are learning medicines by their active ingredient name.
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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FDA Law Blog: Biosimilars
JUNE 11, 2023
This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA.
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. 2005 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2012/1916). cited 2024May].
PharmaShots
APRIL 13, 2023
The company also granted exclusive marketing rights to Meda for Cibacen and Cibadrex in major EU markets for $0.13B In the year 2005, Bayer’s sales depicted an increase of 18%, attributable mainly due to its consumer health business acquired from Roche Abbott achieved a total revenue of $1.4B
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