Drug Channels

NOVEMBER 30, 2020

With drug pricing and benefit coverage top of mind for many Americans, coupled with a volatile election and overall healthcare landscape, the stakes are incredibly high for bio/pharma manufacturers. Staying on the pulse of industry trends, policies and changing regulations has never been more crucial.

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Government Pharma Companies Regulations Drugs 52

H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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Compliance Science Regulations Pharmaceutical Companies 59

Advarra

JULY 19, 2022

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. IRBs are subject to 21 CFR 56 IRBs.

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Packaging FDA Trials Regulations 52

The Pharma Data

NOVEMBER 5, 2020

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. The following files are available for download: View original content: [link]. SOURCE Moberg Pharma. CET on November 6, 2020.

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Marketing Production Regulations Pharma Companies 40

Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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Therapies Virus DNA Clinical Trials 131

Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. Techbio companies have initiated this approach. FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

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Drug Development Science Clinical Trials FDA 59