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.
Pharmacy Is Right For Me
OCTOBER 21, 2022
I worked in Dallas from 95-2001, then moved to NYC, then years later went to the University of Colorado for the NTPD program and received the PharmD. My evenings involve music production, radio show production, podcast production, reviewing new music sent by labels/music promoters, and preparing for gigs.
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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.
PharmaShots
APRIL 20, 2023
In August 2021, the FDA approved an expanded label for Lyumjev® (insulin lispro-aabc injection) 100 units/mL to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. The primary objective was noninferiority (noninferiority margin [NIM]=0.4% And diabetes prevalence continues to rise in children.
PharmaShots
FEBRUARY 21, 2023
FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.
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