Express Pharma
DECEMBER 9, 2024
ISB2001 Phase 1 Dose Escalation Study Design The Phase 1, first-in-human, open-label study is evaluating the safety and anti-myeloma activity of ISB2001 in patients with RRMM. The post Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001 appeared first on Express Pharma.
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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Express Pharma
MARCH 5, 2025
Where is the goodwill we earned when the Father of Generics, our own Dr Yusuf Hamied paved the way for generics way back in the year 2001? True, we are not moral policemen to prevent off-label or illegitimate use, but indulging or encouraging such activities is unpardonable.
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. 20 Good manufacturing practice (GMP) Commission Directive (EU) 2017/1572 (which supplemented Directive 2001/83/EC) lays out the principles and guidelines of GMP in the EU. 2012/1916).
RX Note
JUNE 8, 2023
However, the FDA published the Pregnancy and Lactation Labelling Rule (PLLR) on 3 December 2014, which requires data on medication transfer into breast milk to be included in the product inserts of prescription drug and biologic product applications submitted after 30 June 2015, while labelling for prescription drugs approved on or after 30 June 2001, (..)
RX Note
JUNE 9, 2023
FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
European Pharmaceutical Review
DECEMBER 20, 2023
Draft Report on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC. analysis (Source: L.E.K) Internet] 2023. cited 2023Dec] Available from: [link] European Parliament.
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