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.
European Pharmaceutical Review
NOVEMBER 11, 2022
NTLA-2001, a novel CRISPR/Cas9-based therapy in the first-ever human gene editing trial ( NCT04601051 ) in vivo (in the body), reduced transthyretin (TTR) proteins by at least 90 percent in amyloidogenic transthyretin (ATTR) cardiomyopathy patients, 28 days after a single IV infusion, with benefits lasting four to six months.
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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.
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
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).
European Pharmaceutical Review
JUNE 8, 2023
2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.
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