European Pharmaceutical Review
JANUARY 25, 2024
Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).
Clarivate
NOVEMBER 10, 2022
The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.
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Nixon Gwilt Law
FEBRUARY 27, 2023
Notably, this rulemaking does not propose to implement the “special registration” for telemedicine providers the DEA has been promising since the Ryan Haight Act passed in 2009. Instead, it would create a new regulatory category of the “practice of telemedicine.” This is a telling strategy.
pharmaphorum
AUGUST 24, 2022
A federal judge has ruled that a jury trial will be needed to resolve allegations that Indivior attempted to preserve a monopoly by switching to a sublingual film formulation of Suboxone (buprenorphine/naloxone) in 2009 from an older pill version of the product.
European Pharmaceutical Review
SEPTEMBER 20, 2023
The growing presence of these unintended amino acid sequences in recombinant proteins is a top concern for regulators and drug manufacturers due to the ability of these mutations to cause higher order structural problems, potentially affecting efficacy and safety. While SVs are typically present at less than 0.1
Clarivate
NOVEMBER 13, 2023
The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Data and insights gleaned from these projects have most recently been presented at industry conferences and events, including ISPOR.
Salesforce
JUNE 11, 2019
Our large and growing ecosystem of technology partners and independent software vendors (ISV) offers our customers tailored solutions across the R&D, Quality, and Safety landscape. If you’re going to DIA, please j oin us at DIA Booth #2009 to start a conversation (#DIA2019) and let’s get better together.
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