2018 Adverse Reactions Labelling 
Big Molecule Watch
SEPTEMBER 25, 2023
Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”
RX Note
FEBRUARY 11, 2024
Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. Viscous lidocaine has been associated with serious adverse reactions ( including death ) in young children being treated for mouth pain, including teething.
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pharmaphorum
OCTOBER 19, 2020
The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients. months compared with 4.1
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.
LifeProNow
APRIL 9, 2023
These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. of patients.
Quality Matters
OCTOBER 13, 2021
There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. This is what has been happening with nitrosamine impurities.
The Thyroid Pharmacist
JULY 8, 2022
As of 2018, there have been at least two active studies underway to gain more definitive results, the GRASS (Graves’ Disease Selenium Supplementation) and the CATALYST (The Chronic Autoimmune Thyroiditis Quality of Life Selenium Trial). Published 2018 Sep 26. doi:10.1155/2018/3763565. 2018 Jul 30. 2018 Jul 30.
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